Catheter assembly

ABSTRACT

Novel catheter constructions comprising thin covering or wrapping materials such as polymer films. A catheter provided with a guidewire catheter lumen having a thin covering that is easily punctured by a guidewire at virtually any desired point along the catheter length. The thin covering may be integral with the catheter shaft, or may be a separate component that covers only the portion of the catheter shaft immediately adjacent the outer portion of the guidewire lumen, or may be a thin tubular construct that surrounds the entire catheter shaft. Moreover, polymer film can be used in combination with one or more elements to produce novel catheter constructions.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation-in-part of U.S. patent applicationSer. No. 10/895,817, filed Jul. 21, 2004, which is acontinuation-in-part of U.S. patent application Ser. No. 10/402,083,filed Mar. 28, 2003, (entitled PUNCTURABLE CATHETER) which is acontinuation-in-part of U.S. patent application Ser. No. 10/346,977filed Jan. 17, 2003, now abandoned entitled ADJUSTABLE LENGTH CATHETER).

FIELD OF THE INVENTION

The present invention relates to the field of catheters. Moreparticularly, the invention relates to catheters intended for thedelivery to a patient of, for example, therapeutic agents or devices.

BACKGROUND OF THE INVENTION

A variety of different therapies can be delivered within the human bodyby catheter devices. Therapeutic devices such as dilation balloons,occlusion balloons, thrombectomy treatment devices, stents, and embolicfilters, and therapeutic agents such as drugs and radiation sources, maybe positioned at or near the distal end of the catheter for delivery toa desired site within the body. The proximal end of the catheter isconsidered to be the end that remains outside of the body, manipulatedby the medical practitioner.

To aid in positioning of the distal end of the catheter within the body,typically the distal end of a guidewire is first navigated to thetreatment area. After the guidewire has been positioned, the wire canthen be used to guide the distal end of the catheter into place.Additionally, a guide catheter may be used to further facilitate thepositioning of the guidewire and/or delivery catheter. The interactionbetween the guidewire and the catheter is critical, as the physicianneeds to easily track the distal end of the catheter along the path ofthe guidewire. A number of interaction issues can arise, including butnot limited to, having to use more than one person, having to use a longwire, having the advancement of the catheter affect the position of thewire, having the catheter not able to track the wire through tortuousanatomy, having excessive friction between the catheter and the wire,and having a difference between the amount of axial motion applied tothe proximal end of the catheter and the amount of axial movement at thedistal end of the catheter.

In various attempts to address these issues, a number of catheterdesigns have been introduced that have defined the interaction betweenthe guidewire and the catheter. Two of the primary applications ofcatheter systems are percutaneous transluminal coronary angioplasty(PTCA) and coronary stent delivery. Two main types of catheter designs,over-the-wire (OTW) and rapid-exchange (RX), dominate theseapplications. Each of these designs has its advantages anddisadvantages. OTW catheters track over their entire length on aguidewire, which allows them to follow the wire easily and allows thedirect transmission of longitudinal force over the guidewire.Additionally, these catheters allow for guidewires to be exchanged oncethe catheter has been advanced into position, which may be desirablewhen different guidewire attributes (e.g., tip curvature or radiopaquemarkers) are needed. However, these systems require the use of a longguidewire (e.g., 300 cm in length) and cannot be effectively operated byone person.

RX catheters typically use shorter guidewires (e.g., 180 cm in length)which allow the catheter to be operated by a single physician. Thephysician is able to hold the guide catheter and guidewire with one handwhile using his other hand to advance or retract the catheter along theguidewire. However, because the entire length of the RX catheter doesnot slide over the guidewire, the direct transmission of longitudinalforce along the path of the guidewire may be compromised, and wireexchange can not be performed once the proximal catheter guidewire portis advanced into the patient.

Furthermore, it is not uncommon for OTW and RX catheters (among others)to be constructed by a plastic (or polymer) extrusion process.Producing, for example, an OTW or RX catheter with a tight tolerance,with a dual lumen construction can be difficult and expensive via anextrusion process.

Among various further catheter designs intended for stent delivery is asystem taught by U.S. Pat. No. 5,534,007 to St. Germain et al. Thissystem includes a tubular exterior sleeve with an adjustable lengthsection that, under axial compression, shortens via corrugations tocause another sleeve at the distal end of the catheter to be withdrawnin a proximal direction, releasing the stent. The overall length of thecatheter remains the same during the axial compression of the exteriorsleeve, and in particular, the length of the guidewire lumen is notadjustable.

U.S. Pat. Nos. 5,334,147 and 5,380,283 to Johnson teach the constructionof a balloon catheter having a proximal portion that includes anaperture through the wall of the catheter into the guidewire lumen. Theaperture is covered by a frangible wall (e.g., a thin-walled tube sealedto the catheter body in a position to cover the aperture portion). Thefrangible wall may be punctured by a guidewire, allowing the guidewireto exit the catheter guidewire lumen via the aperture.

U.S. Pat. No. 5,472,425 to Teirstein describes a catheter having aguidewire lumen covered by a rupturable membrane that extends alongsubstantially the entire length of the catheter, whereby the membranemay be intentionally punctured at any desired location by the guidewire.The use and general construction of the catheter are related, althoughno materials or specific constructions for the rupturable membrane aretaught.

U.S. Pat. No. 6,423,032 to Parodi describes methods and apparatus forremoving emboli during an angioplasty, stenting, or surgical procedurecomprising a catheter having an occlusion element, an aspiration lumen,and a blood outlet port in communication with the lumen, a guide wirehaving a balloon at its distal end, a venous return catheter with ablood inlet port, and tubing that couples the blood outlet port to theblood inlet port. Also described is apparatus for occluding the externalcarotid artery to prevent reversal of flow into the internal carotidartery. The pressure differential between the artery and the veinprovides reverse flow through the artery, thereby flushing emboli.

U.S. Pat. No. 6,929,634 to Dorros et al. describes methods and apparatusfor treatment of stroke. Specifically described is a catheter having adistal occlusive member capable of being disposed in the common carotidartery of the hemisphere of the cerebral occlusion. Retrograde flow maybe provided through the catheter to effectively control cerebral flowcharacteristics. Under such controlled flow conditions, a thrombectomydevice may be used to treat the occlusion, and any emboli generated aredirected into the catheter.

SUMMARY OF THE INVENTION

The invention relates to novel catheter constructions comprising thincovering or wrapping materials such as polymer films. A first aspectrelates to a catheter provided with a guidewire catheter lumen having athin covering that is easily punctured by the back end (i.e., theproximal end) of a guidewire at virtually any desired point along thecatheter length. The thin covering may be integral with the cathetershaft, or may be a separate component that covers only the portion ofthe catheter shaft immediately adjacent the outer portion of theguidewire lumen, or may be a thin tubular construct that surrounds theentire catheter shaft. The covering is preferably adequately translucentto allow for good visualization of the location of the back end of theguidewire in order to enable puncturing of the covering at the desiredlocation along the length of the catheter shaft. The catheter shaft ispreferably made of a material having a color that provides goodvisibility against an operating field, and more preferably is luminousor phosphorescent either entirely or in part. Materials suitable for thecatheter shaft are polymeric materials well known in the art; thecatheter shaft may optionally be provided with metallic stiffeningcomponents such as wires, wire braids or hypotubes along all or part ofthe catheter length.

In an aspect of the invention, the thin covering or wrapping material ismade from a thin tape of porous expanded polytetrafluoroethylene (ePTFE)that can be helically wrapped about the exterior of a catheter shaft.Most preferably, the wrapping is accomplished in two opposing directionsparallel to the length of the catheter shaft, resulting in a bias-plyconstruction. This thin covering offers good transparency and is easilypunctured by the end of a guidewire, and yet is resistant to tearing atthe puncture site.

Other materials may be used for the puncturable thin covering, includingpolyethylene terephthalate (PET). These materials may also offer goodtranslucency, but may be less tear resistant than the helically wrappedePTFE thin coverings.

The thin covering (either integral with the catheter shaft or a separatecovering) may optionally be provided with a multiplicity of small,pre-formed openings through the thickness of the covering to allow forpassage of the back end of a guidewire through any of these openings.The openings would preferably be arranged in a single line extendingdirectly above the guidewire lumen.

The thin covering may optionally be in the form of a braid orhelically-wound filaments that allow the guidewire to be passed throughany of the multiplicity of openings or interstices that exist betweenadjacent filaments of the braid or winding. The braid or winding may beof either various polymeric or metallic materials. The braid or windingmay be exposed around the entire exterior of the catheter shaft oralternatively may be exposed over only the side of the guidewire lumenclosest to the exterior of the catheter shaft.

For many embodiments, the guidewire lumen is in the form of a slot madeinto the catheter shaft, with the slot provided with the thin covering.Preferably, the slot extends for most or even all of the length of thecatheter shaft. It may optionally extend through a balloon or otherdevice located at the distal end of the catheter. The slot is coveredwith a thin tubular covering that coaxially encloses the entire cathetershaft or alternatively a strip of thin tape-like covering material thatcovers the slot and is adhered to the surface of the catheter shaftimmediately adjacent both sides of the slot. A multiplicity ofpre-formed openings may be provided through the thin covering as notedabove. Also as noted above, the slot covering material may take the formof a braid or winding of filaments. This braid or winding of filamentsmay optionally be covered with a thin polymeric tube except for thefilaments immediately over the top of the slot which preferably remainexposed and allow for passage of the end of a guidewire through anyinterstice between adjacent filaments.

Other embodiments using the catheter shaft may be provided with apuncturable tubular form inserted into the slot. This tubular form maybe made with filaments braided into the tubular form, or a tubular formmade of helically wound filaments or from a thin polymeric material,with the tube having an inside diameter adequately large to accommodatea guidewire of the desired size. These tubes are fitted and secured intothe slot formed into the catheter shaft, with the result that the outersurface of the braided or helically wound tube covers the exposed partof the slot and allows for the back end of a guidewire contained withinthe tube to be passed through any interstice between adjacent filamentsof the braided or helically wound tube. When the tubular form is madefrom the thin polymeric material, the resulting tube inserted into thecatheter shaft slot is puncturable at any desired location by the backend of a guidewire.

The ability of the catheter to be punctured by the back end of aguidewire at any desired location along the length of the puncturablesection of the catheter allows the catheter assembly to be usedeffectively as desired in either OTW or RX mode.

In addition to being puncturable by the back end of the guidewire, theguidewire catheter lumen may optionally be made to be adjustable inlength. The adjustable length catheter guidewire lumen is the conduit,or catheter, or tube, or space that contains the guidewire or provides aspace for the passage of a guidewire therethrough. The space may beadjustable in length, as will be further described.

By adjustable length is meant that the length of the adjustable lengthguidewire catheter lumen may be changed by the application of easilyapplied manual axial force. In its axially extended or fully lengthenedstate, the adjustable length guidewire catheter lumen is at least 10%longer than when in the axially compressed, fully shortened state. Morepreferably, the adjustable length guidewire catheter lumen is adjustableby an amount of at least about 20%, or 30%, or 40%, or 50%, or 75%, or100%, or 200%, or 400%, or 1000%, or 2000%.

The adjustable length guidewire catheter lumen is adjustable in lengthby virtue of being scrunchable. This means that this tubular componentis easily shortened in length under axial force, without telescoping asby the successive sliding of overlapped concentric tubular sections.Various means of providing a scrunchable tube for use as the adjustablelength guidewire catheter lumen include the provision of corrugations(i.e., wrinkles, or accordion pleats or folds), or by the use of aporous tube that compresses axially by reduction in total void space.These are further described below.

In a further aspect of the invention, polymer film is used incombination with one or more elements to produce novel catheterconstructions. For example, polymer film can be wrapped about one ormore catheter elements to produce useful catheters. Moreover, catheterscan be formed by wrapping a suitable polymer film about a mandrel andremoving the mandrel to obtain a catheter having at least one lumentherein. Moreover, polymer film can be provided in tubular form, whichmay be a heat shrinkable material such as a tube comprising polyethyleneterephthalate (PET).

Suitable materials for the adjustable length lumen and the polymer filminclude ePTFE, polyethylene terephthalate (PET), polyamide, or otherthermoplastic or thermoset polymers, or other such relatively inelasticmaterials. Alternatively, an elastomeric material may be used, whichmaterials elongate by the application of an extending axial force. Theterm “elastomeric” is intended to describe a condition whereby a polymerdisplays stretch and recovery properties similar to an elastomer,although not necessarily to the same degree of stretch and/or recovery.

In a further aspect of the invention wire-based guidewires and catheteror micro-catheter systems are provided. Such systems comprise at leastone longitudinally extending wire having a length and at least an outersurface with at least one cut therein, a proximal end, and a distal end.The wire-based device further comprises polymer film covering at least aportion of the outer surface of the at least one wire. The wire-baseddevice further includes at least one therapeutic device and/or adiagnostic device, located at the distal end thereof. Such systems maycomprise one or more balloon on wire devices as described further hereinin more detail.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A shows a longitudinal cross section of a catheter having apuncturable guidewire lumen covering.

FIG. 1B shows a longitudinal cross section of the catheter of FIG. 1A inuse with the catheter, the guidewire having punctured the puncturableguidewire lumen covering.

FIGS. 1C and 1D show transverse cross sections of the catheter of FIG.1B with the guidewire within and without the puncturable section.

FIG. 1E shows a longitudinal cross section of a catheter that is avariation of the design shown in FIGS. 1A and 1B wherein the guidewireoperates in a slot provided in the exterior wall of a lumen of thecatheter.

FIGS. 1F, 1G and 1H show transverse cross sections taken at threedifferent locations along the length of the catheter shown in FIG. 1E.

FIG. 2A shows a perspective view of a preferred slotted catheter shaft.

FIG. 2B is a perspective view of the preferred slotted catheter shaft ofFIG. 2A provided with a helical wrap of a polymeric tape that forms apuncturable thin cover over the slot.

FIG. 2C is a perspective view of the preferred slotted catheter shaft ofFIG. 2A provided with a puncturable thin cover in the form of a thintubular sheath.

FIG. 2D is a perspective view of the catheter shaft of FIG. 2C whereinthe thin tubular sheath is formed by a cigarette wrap.

FIG. 2E is a perspective view of the preferred slotted catheter shaft ofFIG. 2A provided with a puncturable thin cover in the form of a strip ortape of a polymeric material adhered over the surface of the cathetershaft immediately adjacent to both sides of the slot.

FIG. 2F is a perspective view of an alternative embodiment wherein thepuncturable guidewire lumen covering is integral with the cathetershaft.

FIG. 2G is a perspective view of an alternative embodiment wherein thethin cover over the guidewire lumen is provided with a multiplicity ofpre-formed openings which allow passage of the back end of a guidewirethrough any opening chosen by the user.

FIGS. 3A-3C are transverse cross sectional views showing variations ofthe embodiment described by FIG. 2E

FIG. 4A is a perspective view of the preferred slotted catheter shaft ofFIG. 2A provided with a puncturable thin cover in the form of a braid.

FIG. 4B is a perspective view of the braid-covered catheter shaft ofFIG. 3A further provided with a thin exterior tubular sheath over thebraid.

FIG. 4C is a perspective view of the braid-and-sheath covered cathetershaft of FIG. 3B wherein the portion of the sheath covering the catheterslot has been removed.

FIG. 4D is a perspective view of catheter shaft with an alternativebraid-covered slot wherein a braided tube is fitted and secured into theslot.

FIG. 4E is a variation of FIG. 4A wherein the braided tubular cover isreplaced with a helically wound tubular cover.

FIG. 4F is a variation of FIG. 4D wherein the braided tube is replacedwith a helically wound tube.

FIG. 4G is a variation of FIGS. 4D and 4F wherein the tubular cover ismade from a thin polymeric material.

FIG. 5 shows a longitudinal cross section of a basic embodiment of thecatheter of the present invention, without a y-fitting but including ahub on the proximal end of the inflation lumen, a puncturable adjustablelength guidewire catheter lumen (shown in its axially compressed orshortened state) located distal to the hub and a tubular slider forcontrolling the proximal end of the adjustable length lumen.

FIG. 6 is a perspective view of a tool useful for bending of thecatheter shaft during puncturing of the thin puncturable cover by theback end of a guidewire.

FIG. 7A is a perspective view of a catheter construction according tothe present invention, utilizing a polymer film wrap.

FIG. 7B is a perspective view of a catheter construction according tothe present invention utilizing a polymer film wrap.

FIG. 7C is a perspective view of a catheter construction according tothe present invention utilizing a polymer film wrap.

FIG. 7D is a catheter construction according to the present inventionwherein polymer film is contacting the outer surfaces of twolongitudinally extending elements.

FIG. 8A is a cross-section of a catheter construction according to thepresent invention.

FIG. 8B is a cross-section of a catheter construction according to thepresent invention.

FIG. 8C is a cross-section of a catheter construction according to thepresent invention.

FIG. 8D is a cross-section of a catheter construction according to thepresent invention.

FIG. 8E is a cross-section of a catheter construction according to thepresent invention.

FIG. 8F is a cross-section of a catheter construction according to thepresent invention.

FIG. 9A is a cross-section of a catheter construction according to thepresent invention.

FIG. 9B is a cross-section of a catheter construction according to thepresent invention.

FIG. 9C is a cross-section of a catheter construction according to thepresent invention.

FIG. 10 is a cross-section of a catheter construction according to thepresent invention.

FIG. 11 is a partial cross-section and perspective view of a catheteraccording to the present invention.

FIG. 12 is a cross-section of a catheter according to the presentinvention.

FIG. 13 is a cross-section of a catheter according to the presentinvention.

FIG. 14 is a cross-section of a catheter according to the presentinvention.

FIG. 15 is a cross-section of a catheter according to the presentinvention.

FIG. 16 is a cross-section of a catheter according to the presentinvention.

FIG. 17 is a cross-section of a catheter according to the presentinvention.

FIG. 18A is a perspective view of a catheter construction according tothe present invention.

FIG. 18B is a perspective view of a catheter construction according tothe present invention.

FIG. 19A is a cross-section of a catheter according to the presentinvention.

FIG. 19B is a cross-section of a catheter according to the presentinvention.

FIG. 20A is a cross-section of a catheter according to the presentinvention.

FIG. 20B is a cross-section of a catheter according to the presentinvention.

FIG. 21 is a cross-section of a catheter according to the presentinvention.

FIG. 21A is a cross-section of a catheter according to the presentinvention.

FIG. 22A is a perspective view of a catheter according to the presentinvention.

FIG. 22B is a perspective view of a catheter according to the presentinvention.

FIG. 22C is a cross-section of a catheter according to the presentinvention.

FIG. 22D is a perspective view of a catheter according to the presentinvention being advanced into a vessel or artery.

FIG. 22E is a perspective view of a catheter according to the presentinvention.

FIG. 23 is a perspective view of a catheter construction according tothe present invention utilizing two small profile wire based devices.

FIG. 24 is a partial cross-section of a wire-based device according tothe present invention.

FIG. 25 is a side view of a wire-based device according to the presentinvention.

FIG. 26 is a side view of a microcatheter according to the presentinvention.

FIG. 27 is a side view of a microcatheter and a wire-based deviceaccording to the present invention.

FIG. 28 is a side view of a wire-based device according to the presentinvention.

FIG. 29 is a partial cross-section of a wire-based device according tothe present invention.

FIG. 30 is a longitudinal cross-section of a wire-based device accordingto the present invention.

DETAILED DESCRIPTION OF THE INVENTION

FIGS. 1A-1H describe a catheter 10 of the present invention providedwith a thin, puncturable cover 102 over the guidewire lumen 18.Typically, catheter 10 may include devices such as a catheter balloon 20and/or stent 21 at its distal end 17 and a hub 14 at the proximal end16. As shown by FIGS. 1A-1H, the thin, puncturable cover 102, in thisinstance a thin-walled tubular sheath 13 (forming guidewire lumen 18)designed to be punctured by the back end of a guidewire 19 (or othersuitable means), may be placed coaxially about the inflation lumen 22.The length of the thin tubular sheath 13 may extend over all or part ofthe length of catheter shaft.

After feeding guidewire 19 through the distal section of the guidewirelumen 18 and into the thin-walled tubular sheath 13, the physician maychoose any desired location along the length of thin-walled tubularsheath 13 at which to puncture the thin, puncturable cover 102 with theguidewire 19. In this fashion the physician may select his preferredlength of the guidewire lumen 18.

FIG. 1A shows a longitudinal cross section of a catheter 10 having apuncturable guidewire lumen covering 102, while FIG. 1B shows alongitudinal cross section of the catheter of FIG. 1A in use with theguidewire 19, the guidewire having punctured the puncturable covering102. FIGS. 1C and 1D show, respectively, transverse cross sections ofthe catheter of FIG. 1B with the guidewire 19 within and outside of thepuncturable section 102.

FIG. 1E shows a longitudinal cross section of a catheter that is avariation of the design shown in FIGS. 1A and 1B wherein the guidewireoperates in a slot 104 provided in the exterior wall of a lumen of thecatheter. It is apparent that the thin, puncturable cover 102 may beprovided only over this slot portion and is not required to enclose theentire circumference of the inner catheter. FIGS. 1F, 1G and 1H showtransverse cross sections taken at three different locations along thelength of the catheter shown in FIG. 1E.

The puncturable guidewire lumen may be made in a variety of ways.

In a preferred embodiment, catheter 10 including inflation lumen 22 andguidewire lumen 18 is made using a catheter shaft 15 as shown in theperspective view of FIG. 2A wherein guidewire lumen 18 is in the form ofa slot 104. The catheter shaft 15 may be made in this form by extrusion(using any known polymeric material suitable for the application), ormay alternatively be extruded with fully enclosed lumens and then havethe extruded material covering the guidewire lumen skived away.Preferred materials will be of a color offering good contrast with theoperational field, and most preferably are fluorescent orphosphorescent.

Optionally, such a catheter shaft may be stiffened along all or part ofits length as necessary by the inclusion of stiffening wires runningparallel to the longitudinal axis of the catheter, or by adding atubular metal reinforcing braid to the catheter shaft, or by inserting alength of metal hypotube, tubular braid or helically wound wire into theinflation lumen 22. These stiffening methods may be used in combinationif desired. For simplicity, these well-known stiffening methods are notshown in the figures.

If it is desired to use a hypotube to stiffen only a portion of thelength of the catheter shaft, it may be desirable to cut ahelically-oriented slot through the wall of the end of the hypo tubethat will be located within the length of the catheter shaft to reducethe abrupt stiffness transition of the stiffened section to theunstiffened section.

As shown by the perspective view of FIG. 2B, the slotted catheter shaft15 is provided with a helically-wrapped covering of tape 24. Preferably,the wrapping is applied in two layers wherein adjacent wrappings haveoverlapping edges and the second layer is applied over the first with anopposite pitch, meaning that the two wrappings are applied beginningfrom opposite ends of the catheter shaft 15. The use of the two layersof tape 24 wrapped from opposing directions results in a strong coveringthat is resistant to tearing following puncture by the guidewire backend.

While a variety of thin, flexible polymer materials such aspolyethylene, polypropylene, polyamide, polyethylene terephthalate, etc.may be used for the tape 24. Porous polymers, optionally provided with athin, non-porous coating, may be advantageously used because of theirexcellent flexibility. Tape 24 is most preferably made from a thinporous expanded PTFE (ePTFE) film that has been provided with a porousor non-porous coating of a thermoplastic such as a thermoplasticfluoropolymer, preferably fluorinated ethylene propylene (FEP). ePTFEfilms are generally made as taught by U.S. Pat. Nos. 3,953,566 and4,187,390 to Gore. Most preferred ePTFE films for the presentapplication are taught by U.S. Pat. No. 5,476,589 to Bacino. Theconstruction of thin, helically-wrapped tubes from ePTFE films andthermoplastic-coated ePTFE films, and the method of providing thecoating onto the ePTFE films, are taught by U.S. Pat. No. 6,159,565 toCampbell et al.

An example of a helically-wrapped catheter shaft as shown by FIG. 2B wasmade using an FEP-coated ePTFE tape. The tape had a width of about 6 mmand a thickness of about 0.005 mm. The ePTFE had mean fibril length ofabout 50 microns and a bulk density of about 0.5 g/cc. The ePTFE filmwas provided with a non-porous coating of FEP on one side. After thecoated film was cut into a narrow tape, the tape was helically wrappedonto a stainless steel mandrel of diameter larger that the outsidediameter of the chosen catheter shaft. The first layer of the wrappingwas applied with the FEP coated side of the tape facing away from themandrel and the second layer was wrapped in the opposite direction fromthe first with the coating facing toward the mandrel and first layer.The wrapped mandrel was then heated for about 8 minutes in a convectionoven set at 320° C. to melt-bond the helically-wrapped layers of thetube together. Following removal from the oven and cooling to about roomtemperature, the helically-wrapped tube was removed from the mandrel andfitted over a length of the desired catheter shaft 15 that was shorterthan the length of the helically-wrapped tube. The opposite ends of thehelically wrapped tube were gripped using pliers and tension was appliedto cause the helically-wrapped tube to elongate and reduce in diameter,thereby tightly conforming to the outer surface of the catheter shaft.The ends of the helically-wrapped tube were adhered to the outer surfaceof the catheter shaft using a cyanoacrylate adhesive. The ends of thecovered catheter shaft 15 were then transversely cut to the desiredlength with a sharp blade. If desired, the hub component typicallyfitted to the proximal end of the catheter shaft may be fitted over thehelical wrap.

The thickness of the thin tubular tape covering 102 was determined to beabout 0.012 mm by measuring the diameter of the catheter shaft at 90degrees to the orientation of the slot 104 using a laser micrometer bothbefore and after the application of the helically-wrapped covering.

The covered catheter 10 that resulted from this process retained thegood flexibility of the precursor catheter shaft 15 prior to covering.When a guidewire 19 was inserted into the guidewire lumen 18, the thincover 102 exhibited good transparency, meaning that the back end of theguidewire 19 was visible to the unaided eye as it passed through thelength of the guidewire lumen 18. It was not difficult to stop theprogression of the guidewire back end at a desired point along thelength of the guidewire lumen, and by bending the catheter with theguidewire slot oriented to the outside of the bend, the covering 102 wasreadily punctured by the back end of the guidewire 19. When a largeportion of the length of the guidewire was pulled through the puncturesite, the puncture site exhibited no sign of tearing or of appreciableenlargement of the puncture.

FIG. 2C is a perspective view of a catheter 10 including a tubularsheath 13 for use as the thin puncturable cover 102 over slot 104. Thesheath may be in the form of a thin extruded tube of, for example, PET.It may be applied similarly to the above-described helically-wrappedtube using a tubular sheath 13 of slightly larger inside diameter thanthe outside diameter of the catheter shaft 15 to be covered. The outersurface of the catheter shaft 15 may be provided with a thin coating ofa suitable adhesive if desired, after which the thin tubular sheath 13is fitted over the catheter shaft 15 and tensioned to cause it toelongate and reduce in diameter to conform to the outer surface of thecatheter shaft 15. Sheath 13 may also be made from a shrink tubing thatis heated after being fitted about the outer surface of the cathetershaft 15 to cause it to conform thereto.

FIG. 2D is a perspective view of the catheter 10 of FIG. 2C wherein thethin tubular sheath is formed by a cigarette wrap, wherein thebraid-covered catheter shaft is additionally covered by an adequatelylong strip of thin polymeric material that has a width equal to orslightly greater than the circumference of the braid covered cathetershaft. This strip is wrapped around the catheter shaft as shown andadhered by thermal bonding or by the use of a suitable adhesive.

Another alternative for the puncturable thin cover 102 is shown in theperspective view of FIG. 2E wherein a thin tape 24 is adhered to theouter surface of the catheter shaft 15 adjacent to the edges of slot104. In another embodiment, the guidewire lumen 18 may be extruded orotherwise formed to have an integral, thin, puncturable covering 102 asshown by the perspective view of FIG. 2F. FIG. 2G is a perspective viewof the catheter 10 of FIG. 2F wherein pre-formed openings 25 are formedthrough the thin puncturable cover 102 to allow passage of the back endof a guidewire through any pre-formed opening 25 chosen by the user. Itis apparent that these pre-formed openings 25 may be used with many ofthe various described embodiments.

FIGS. 3A-3C show transverse cross sectional views that represent avariation on the embodiment of FIG. 2E. As shown by FIG. 3A, tape cover24 may be provided so as to increase the space available in theguidewire slot 104 by applying the tape so that it bridges the slot withadditional tape width, resulting in the raised aspect shown by this thinpuncturable cover 102. This can allow for the use of a larger guidewireif desired. When slot 104 is unoccupied by a guidewire, the thin andflexible tape 24 may take on a non-uniform appearance, giving theguidewire lumen and thin puncturable cover 102 an irregular crosssection as shown by FIGS. 3B and 3C. It is apparent that the appearanceof each of these three transverse cross-sections may exist at differentlocations along the length of the same catheter.

The puncturable cover 102 may also be made using threads, wires or otherfilaments. For example, threads may be wound around a slotted cathetershaft 15 in various desired patterns to form a covering over a guidewirelumen 18 that effectively contains a guidewire 19 but allows the backend of the guidewire to be passed through any of the multiplicity ofspaces between adjacent threads of the wrapped covering. The threadsmay, for example, be provided as a helically-wrapped pattern, a braidedpattern or a knit (e.g. warp knit) pattern. By orienting the threads inclose proximity to one another, the guide wire will preferentially staywithin a lumen of which the thread defines a portion of the wall.However, the end of the wire can be maneuvered to exit this lumenbetween the threads. By using a wound thread, the structure is neverdamaged allowing the catheter to be reused multiple times. Bycontrolling the spacing between adjacent threads, the ease of which theend of the wire exits the lumen may be altered. Preferentially, smalldiameter threads can be used, for example, with diameters from 0.012 to0.5 mm. Any variety of thread materials may be used, included commonthermoplastic (e.g., polyamide, polypropylene, polyester, etc),thermosets, fluoroplastics (e.g., ePTFE) or various metal wiresincluding stainless steels and nitinol.

As shown by the perspective view of FIG. 4A, a catheter shaft 15 isover-braided with filaments 31. The braid may have numerousconfigurations including, but not limited to, number of filaments, pickcount and pitch angle. As well, filaments 31 may be of various crosssections such as round, square or rectangular.

FIG. 4B shows a preferred embodiment wherein catheter 10 of FIG. 4A isprovided with an outer sheath 13 applied over catheter shaft 15 andbraid 31 and attached by any of various methods such as heat oradhesive. Following the addition of sheath 13, an appropriately-sizedmandrel is inserted into the guidewire lumen 18. The catheter is mountedin a laser (e.g., a 20 watt CO² laser, Applied Laser Technology,Beaverton Oreg.) with the laser beam directed to slot 104. The laser isused to ablate the polymer material of sheath 13 covering slot 104 alongthe desired length of the catheter 10, resulting in cutaway slot 33through sheath 13 exposing slot 104 beneath braid 31. The laser powerparameters are such that the polymer material of sheath 13 is ablatedyet metallic braid filaments 31 are left undamaged. The indwellingmandrel effectively blocks the laser energy from damaging the oppositeside of the catheter shaft 15. The resultant catheter 10 is left with abraided underlying chassis and an outer polymer sheath 13 in which a“strip” of braid is exposed directly above slot 104, whereby guidewirelumen 18 lies immediately below the exposed strip 33 of braid 31. Aclinician may then use the back end of a guide wire to part the braidfilaments at any suitable user-defined position along this strip 33,thus exiting the guidewire from catheter 10 through the selectedinterstice of braid 31.

FIG. 4D describes an alternative embodiment whereby a braided tube 37 isprocured, this tube having an outside diameter corresponding to theinside diameter of slot 104 of catheter shaft 15. The braided tube 37 ismade to have a suitable inside diameter to provide adequate clearancefor passage therethrough of an intended guidewire. Braided tube isfitted into slot 104 by interference, or by joining with an adhesive. Inuse, as with the previously described braided construct, the guidewiremay be passed through any desired interstice of the braid 31 to exitcatheter 10.

FIG. 4E describes a variation of FIG. 4A wherein braid 31 is replaced byhelically wound filament 41, which may be of polymeric or metallicmaterial. FIG. 4F shows an alternative to FIG. 4D wherein braided tube37 is replaced by helically wound tube 47. Again, the helically woundtube may be of polymeric or metallic material. The embodiments of FIGS.4E and 4F are desirable in that the space between adjacent helicalwindings will widen when the catheter shaft is bent with the exposedwinding on the outside of the bend, making it easier to pass the backend of a guidewire through any desired space between adjacent helicalwindings.

FIG. 4G is a perspective view of an alternative embodiment to thoseshown by FIGS. 4D and 4F wherein tube 49 inserted into slot 104 is madefrom a thin polymeric material. This tube is preferably made byhelically wrapping a thermoplastic-coated ePTFE film about a mandrel ofsuitable size, bonding the wrapping together to result in a cohesivetube, inserting the tube and mandrel into slot 104 and finally removingthe mandrel. Alternatively if desired, the mandrel may be removed fromwithin the tube prior to insertion of the tube 49 into slot 104.

FIG. 5 shows a longitudinal cross section of an alternative embodimentof catheter 10, including a hub 14 on the proximal end 16 of theinflation lumen 22. In this embodiment, catheter 10 is provided with apuncturable adjustable length guidewire lumen 18 that is in the form ofa thin tubular sheath 13 puncturable by guidewire 19 as shown. A tubularslider 24 is used in place of a conventional y-fitting, distal to hub 14for attachment and control of the proximal end of the adjustable lengthguidewire catheter lumen 18. Adjustable length guidewire catheter lumen18 is shown in its axially compressed or shortened state. Tubular slider24 is provided with only a small clearance between the inner diameter ofslider 24 and the outer diameter of the inflation lumen 22. Adjustablelength guidewire catheter lumen 18 may be made from a variety of thin,flexible polymer materials such as polyethylene, polypropylene,polyamide, polyethylene terephthalate, etc. Porous polymers, optionallyprovided with a thin, non-porous coating, may be advantageously usedbecause of their excellent flexibility. Adjustable length guidewirecatheter lumen 18 is preferably made from a porous expanded PTFE (ePTFE)film that has been provided with a porous or non-porous coating of athermoplastic fluoropolymer as described previously.

The thin-walled tube is preferably made from an FEP-coated ePTFE filmthat has been cut into a tape (width, e.g., 12.7 mm) and helicallywrapped on a mandrel with the FEP coating placed on the exterior of thewrapping. The helically wrapped tube is then placed into an oven for asuitable time (e.g., 8 minutes in an oven set at a temperature of 320°C.) to thermally bond the overlapped edges of the helical wrappingtogether, thereby forming a coherent tube. After removal from the ovenand cooling, the resulting tube is removed from the mandrel and may beused as the adjustable length lumen component in the catheter of thepresent invention. The ends of this tube may be joined to the adjacentcomponents by overlapping the tube end over the adjacent component andadhering the overlapped areas with an adhesive such as a cyanoacrylate(e.g., Loctite 401, Rocky Hill, Conn.) or an ultraviolet adhesive (e.g.,Loctite 3311). Alternatively, the tube may be everted to orient theFEP-coating toward the lumen, and an adequate heat source may be used tomelt-bond the FEP coating to catheter components such as metalhypotubes.

For use as the puncturable, adjustable length lumen tubular component ofa catheter, the ePTFE tube may be provided with corrugations (e.g.,accordion pleats or folds) with various methods such as those taught byU.S. Pat. No. 3,105,492 to Jeckel and U.S. Pat. No. 6,016,848 to Egres,Jr. Alternatively, it is not required to provide the thin-walled tubewith preformed corrugations as, during axial compression from the fullyextended length to the shortened, fully compressed length, the tube willwrinkle and corrugate in a non-uniform but entirely suitable manner foruse as the adjustable length lumen portion 18 of catheter 10. In anotheralternative, an elastomer may be used for the adjustable length portion18 that would be in its relaxed state prior to loading over theguidewire and would extend into a tensioned condition when the distalend of the catheter is advanced.

Longitudinally extruded and expanded tubes of PTFE, that is, seamlessePTFE tubes, may be used in thinwall form as the puncturable, adjustablelength guidewire catheter lumen. Under axial compression, theinterconnecting fibrils of the node-and-fibril microstructure of ePTFEwill progressively bend and fold. This allows the tubular material toaxially compress in a substantially uniform fashion, retaining thelongitudinal uniformity of the tube wall (macroscopically), withoutcorrugations. This bending of the fibrils within the microstructure ofthe wall of the ePTFE tube during axial compression is described in U.S.Pat. No. 4,877,661 to House et al. Longer mean fibril length tubes arepreferred to maximize the compressible length, e.g., ePTFE tubes ofabout 50 micron or greater mean fibril length.

A catheter having a puncturable, adjustable length guidewire lumen wasconstructed using a very thin walled (e.g., 0.03 mm) sheath material.The sheath material is required to be thin enough to corrugate in smallfolds, allowing the length of the sheath to be reduced to less than 50%of its original length by compressing into the small amplitude folds. A0.01 mm thick ePTFE film provided with a non-porous FEP coating on oneside was chosen for the sheath material. This film was slit to a 6.4 mmwidth, thereby forming a tape.

An ePTFE tube, having an inner diameter of about 1.6 mm and a wallthickness of about 0.13 mm, was fitted over a 1.6 mm diameter stainlesssteel mandrel having a length of about 180 cm. The 6.4 mm wide tape wasthen helically wrapped about the outer surface of the ePTFE tube with a50% overlap, resulting in a helically-wrapped tube covered with twolayers of tape. The resulting assembly was then placed into an airconvection oven set at 320° C. for 8 minutes, after which it was removedfrom the oven and allowed to cool in an ambient environment.

After cooling, the helically-wrapped tube was removed from the mandrelby withdrawing the mandrel from the tube. The end of the extruded tubethat had not been helically-wrapped was clamped in a vise. The end ofthe helical wrapping closest to the vise was simultaneously pinched onopposite sides of the tube using the thumb and forefingers of bothhands, and the helical-wrapping was stripped from the underlying ePTFEtube by everting the helically-wrapped tube while pulling it away fromthe vise.

This thin-walled tube had an approximate wall thickness of 0.03 mm(measured using Mitutoyo Snap Gauge, Model #1 D-C112EBS) and an innerdiameter of approximately 1.7 mm (measured using a certified minus pingauge with a tolerance of 0.01 mm). When this tube was loaded on a 1.2mm diameter mandrel, it was able to be easily compressed to about 5% ofits original length using light digital pressure.

Continuing assembly of the catheter, this sheath was then coaxiallymounted over a conventional Percutaneous Transluminal CoronaryAngioplasty (PTCA) catheter with a maximum outer diameter proximal ofthe balloon of less than approximately 0.040″ (1.02 mm). The PTCAcatheter used was a rapid exchange type, having a proximal guidewireexit port at a location significantly distal of its hub. Prior tomounting the sheath, a 9 Fr (3.0 mm) inner diameter hemostasis y-armvalve (P/N 80348, Qosina, Edgewood, N.Y.) was slid onto the catheterfrom the catheter's distal end (hemostasis valve oriented away from theback end of the catheter). Next, a female luer (P/N 65206. Qosina,Edgewood, N.Y.) was slid onto the catheter and the luer connection ofthese two components was engaged. A 2.0 mm inside diameter by 2.1 mmoutside diameter 304 stainless steel tube (Microgroup, Medway, Mass.)was then swaged down to approximately 1.4 mm inside diameter by 1.6 mmoutside diameter, and then trimmed to a length of approximately 19 mm.

This tube was slid coaxially over the catheter and bonded to the distalend of the female luer with an approximate 6 mm overlap usingcyanoacrylate adhesive (Loctite 401, Loctite Corp., Rocky Hill, Conn.).Next, the helically-wrapped sheath described above was slid over thedistal tip of the catheter and its proximal end attached by sliding itover the exposed end of the hypotube. These overlapped surfaces werebonded using the cyanoacrylate adhesive, after which 2.3 mm insidediameter polyolefin 2-to-1 shrink ratio shrink tubing was fitted overthe junction and heated to conform to the surface of the junction. Thedistal end of the sheath was then trimmed to a length of approximately135 cm, equal to the desired working length of the catheter (i.e. lengthfrom the distal tip of the catheter to the distal end of the strainrelief on the catheter's hub). The distal end of the sheath was thenattached at a location approximately 2 mm distal of the proximalguidewire port in the wall of the PTCA catheter. This attachment wasmade using the cyanoacrylate adhesive between the sheath and catheter,and then over-wrapping this attachment point with cyanoacrylate adhesiveand 0.13 mm diameter ePTFE suture (CV-8, WL Gore and Associates,Flagstaff, Ariz.).

To complete the catheter a hemostasis y-fitting was slid distally on thecatheter until it was just proximal of the proximal hole of the originalPTCA catheter. This compressed the sheath to approximately 15% of itsoriginal approximately 135 mm length. A guidewire was then fed into thedistal tip of the catheter and carefully threaded through the catheter,including the sheath component, and out from the proximal end of thecatheter through the side arm of the y-fitting.

With the guidewire inserted, the user was able to hold the guidewire andhemostasis y-fitting in a fixed position while advancing the distal tipof the catheter relative to the guidewire. Compared to a standardcatheter with a proximal guidewire side port fixed distally of theproximal hub, this inventive catheter significantly improved the abilityof the section of the catheter, distal to the hemostasis y-fitting, totrack the guidewire and allow push forces applied to the proximalportion of the catheter shaft to be transferred directly to the distaltip of the catheter.

FIG. 6 is a perspective view of catheter 10 in use with a puncturingtool 63 that enables puncturing of the cover 102 by the back end ofguidewire 19. While such a tool is deemed unnecessary for manyapplications, for others it may prove advantageous. As shown, tool 63 issimply a short length of tubing that may be either polymeric tubing ormetallic tubing. It is most easily made by bending the short length oftubing (before it is fitted about a catheter) and cutting away a portionof the wall along one side of the tube in the region of the middle ofthe length of the tube, resulting in opening 62. In use, tool 61 isfitted coaxially about catheter 10 and moved along the length ofcatheter 10 to the location at which it is desired to puncture cover 102with the back end of guidewire 19. The tool 61 is oriented so that theopening 62 exposes cover 102 on the side of the catheter where theguidewire is or will be contained. When a guidewire 19 is inserted intothe catheter 10 to the location at which it is desired to puncture thecatheter, with this location exposed at opening 62 in tool 61, both thecatheter 10 and tool 61 are bent as shown by FIG. 6. This bendingresults in puncturing of cover 102 by the back end of guidewire 19. Thebending of catheter 10 is the result of force applied at three points63, with the middle point being on the inside of the bend along themiddle of the length of the bend and the two outer points being on theoutside of the bend at the two opposite ends of the bend. It is apparentthat the tool may take any suitable form that provides this three pointcontact during bending wherein the act of bending enables or results inpuncturing of cover 102 at the desired location by the back end ofguidewire 19. Following puncture, the tool is moved out of the way bysliding it coaxially along the length of the guidewire.

In still a further aspect of the invention, a polymer film wrappingprocess can be used to construct, modify or enhance the properties ofcatheters in a variety of ways. Suitable polymer films include, forexample, flexible polymer materials such as polyethylene, includingultra-high molecular weight polyethylene, polypropylene, polyamide,polyethylene terephthalate, fluorinated ethylene propylene (FEP),perfluoro alkoxy resin (PFA), polyurethane, polyester, polyimide, etc.Porous polymers, optionally provided with a thin, non-porous coating,may be advantageously used because of their excellent flexibility. Thepolymer film is most preferably made from a thin, porous expanded PTFE(ePTFE) film that has been provided with a porous or non-porous coatingof a thermoplastic such as a thermoplastic fluoropolymer, preferablyfluorinated ethylene propylene (FEP). EPTFE films are generally made astaught by U.S. Pat. Nos. 3,953,566 and 4,187,390 to Gore and U.S. Pat.No. 5,476,589 to Bacino. It may be desirable to modify the polymer filmmaterial by providing various fillers to the film. In the case of porouspolymers such as ePTFE film, fillers can be imbibed into the porosity ofthe film by known methods, such as taught by U.S. Pat. No. 5,879,794, toKorleski. Suitable fillers include, for example, fillers in particulateand/or fiber form and can be ceramics, metals, metalloids, carbon, andcombinations thereof. Particularly useful fillers include, for example,radiopaque materials, such as certain metals (e.g. gold) and carbon. Thefillers can be used in combination with desired adhesive materials whenimbibed into the porosity of the polymer film. It may also be desirableto metalize the film on at least a portion thereof. Moreover, ePTFE/FEPlaminate films are taught in U.S. Pat. No. 6,159,565, to Campbell et al.In an aspect of the invention, the polymer film is provided in ahelically-wrapped fashion. In a further aspect of the invention, polymerfilms which exhibit longitudinal shrinkage (e.g., by heat or chemicalactivation) may be particularly attractive for use in certain aspects ofthe invention. Further suitable polymer films can be polymer tubes whichmay be heat shrinkable materials. One such material is PET shrinktubing, which can be provided in very thin (e.g., 0.5 mil) thicknesses.ePTFE is another example of polymer film (or tubing) that may exhibitshrinkage upon either chemical or heat activation.

It may be desirable to provide a suitable adhesive material to at leasta portion of at least one side of the polymer film. Any number ofadhesives may be useful according to this aspect of the invention;including thermoplastic adhesives, thermoset adhesives, pressuresensitive adhesives, heat activated adhesives, chemically activatedadhesives, and UV-curable adhesives, depending upon the particularembodiment and desired results. The adhesives can be provided in liquidor solid form. In an aspect of the invention, adhesives include, forexample, polyamides, polyacrylamides, polyesters, polyolefins (e.g.,polyethylene), polyurethanes, and the like.

Turning to the figures, shown for example in partial isometric FIG. 7Ais a general catheter 150 having two longitudinally extending tubularelements 152A and 152B joined together, in an essentially parallelfashion, by an exterior polymer film wrap 154. The tubular elements 152Aand 152B can each be provided with lumens (151A, 151B) extending for aportion of, or for the entire length of, the tubular element. Thisconfiguration allows two or more simple elements to be joined togetherto form a more complex assembly such as the double lumen catheter shownin FIG. 7A. Thus by the use of polymer film wrap, a double lumencatheter is formed without the complexity and cost of a typical doublelumen extrusion die. Shown in FIG. 7A is polymer film 154 wrapped in anoverlapping helical pattern 156. The film 154 is shown in contact withan exterior or outer surface 158A and 158B of the tubular elements 152Aand 152B. The polymer film can be provided over a portion of eachelement, or the polymer film can be provided over the entire length ofeither or both elements. Tubular elements 152A and 152B can be anylongitudinally extending element and each may optionally have at leastone lumen extending for at least a portion therethrough. The term“essentially parallel” as applied to more than one longitudinallyextending element, includes a “side-by-side” relationship (as shown inFIGS. 7A-7D) as well as configurations that have longitudinallyextending elements in a helical or “twisted” relationship. Although anysuitable polymer film can be used (such as films comprising the polymersmentioned above) in combination with any suitable adhesive (such asthose mentioned above) if an adhesive is desired, ePTFE provided with acoating of FEP is particularly useful. The ePTFE (or other polymer film)can be cut into a tape and wrapped about the elements as shown to securethe elements together. The FEP coating can be either facing toward theelements, away from the elements, or provided on both sides of the ePTFEfilm. Polymer film wrapping may be particularly desirable when joiningtogether two or more dissimilar materials. For example, when joiningtogether a first tubular element comprising PTFE or polyimide to asecond tubular element comprising polyamide (such as PEBAX), theelements may be extremely difficult to join together. A further exampleincludes a first element comprising PTFE and a second element comprisingmetal. Further variations will be appreciated by the skilled artisan. Byproviding a polymer film wrap about the outer surfaces of each element,it is possible to obtain a more secure catheter construction. Moreover,parallel elements 152A and 152B can be fused, bonded or adhered togetherby known means, in addition to being wrapped together with polymer film154. In an aspect of the invention, parallel elements 152A and 152B canbe polymer materials (for example, polyamide, such as PEBAX) which canbe heat fused together, preferably after the polymer film 154 is wrappedabout the elements. This same heating step could be sufficient toactivate the adhesive (if used), or to cause the adhesive to flow, or tocause the polymer film to shrink. Such a heating step can be used in theembodiments described later herein where it may be desirable to heatfuse together two or more polymer elements. Further, although tubularelements 152A and 152B are shown as having substantially the same innerand outer diameters, and as having substantially circular crosssections, it should be understood that the elements can be provided in avariety of sizes and shapes. For example, one element could have a muchsmaller outer diameter, inner diameter, or both, as compared to thesecond element. In such a construction the one element could beconstructed to have a lumen sized to accept a guidewire in a slidingrelationship, while the second element could be sized to have a lumen ofsufficient cross section to function as an inflation lumen thatterminates at one end into the interior of an inflatable member (whichmay have a stent mounted thereon) located on the distal end of thecatheter. Or, the second element could be sized to have a lumen ofsufficient cross-section to allow for advancement and delivery ofdevices such as self-expanding stents, embolic filters, etc. Moreover,the first element could be relatively shorter in length than the secondelement, thus producing the well known rapid-exchange type catheter.Further exemplary variations will be recognized by the skilled artisan.

Shown in partial isometric FIG. 7B is an alternate general catheter 150wherein two tubular elements 152A and 152B are joined together, in anessentially parallel arrangement, by a series of exterior film wraps.Shown are first and second film wrap layers 154A and 154B respectively,each having an overlapping helical pattern 156A and 156B. As shown inFIG. 7B, the helical pattern of the first film wrap is mirrored ororiented 90° to the helical pattern of the second film wrap. Cathetersof the present invention can incorporate one, two, three, four, five,six, seven, eight, nine, ten or more individual layers of filmwrappings. Each individual layer of a film wrap can be of the same, asimilar, or different pattern and/or be of the same, a similar, ordifferent film material.

Shown in partial isometric FIG. 7C is an alternative embodiment of thepresent invention. Shown is a general catheter 150 having two tubularelements 152A and 152B joined together, in an essentially parallelarrangement, by an exterior film wrap 154 having a longitudinal or“cigarette” pattern 160. The film wrap 154 is shown in contact with anexterior or outer surfaces 158A and 158B of each of tubular elements152A and 152B and fully encircles (is wrapped about) the two tubularelements. The film wrap 154 can extend for a portion of the length ofeach element, or the film wrap can be provided over the entire length ofeither or both elements. Shown in partial isometric FIG. 7D is a similarconfiguration of a general catheter 150 of the present invention havinga polymer film 160 contacting an outer surface 158A and 158B of eachelement 152A and 152B, but not wrapped about (i.e. fully encircling) thetwo tubular elements. Again, the polymer film can extend for a portionof the length of each element, or the film can be provided over theentire length of either or both elements.

Numerous shapes, sizes and quantities of tubular elements can be easilyjoined together by polymer film wrapping to form catheters of thepresent invention. Shown, for example, in FIG. 8A is a cross-sectionalview of a catheter of the present invention having a constructionsimilar to that shown in FIG. 7A or 7C.

Specifically, FIG. 8A is a general catheter 150, formed from two tubularelements 152A and 152B (having lumens 151A and 151B) joined together, inan essentially parallel arrangement, by an exterior film wrap 154. Thefilm wrap is in contact with the exterior surfaces 158A and 158B of thetubular elements.

The term “tubular element” includes any longitudinally extendingstructure with or without a through lumen. Thus, tubular elementsinclude but are not limited to tubes with lumens, solid rods, hollow orsolid wires (e.g., guidewires), hollow or solid stylets, metal tubes(e.g., hypotubes), polymer tubes, pull cords or tethers, fibers,filaments, electrical conductors, radiopaque elements, radioactiveelements and radiographic elements. Tubular elements can be of anymaterial and can have any cross-sectional shape including but notlimited to profiles that are circular, oval, triangular, square, polygonshaped or randomly shaped.

Shown in FIG. 8B is a general catheter 150, formed from two tubularelements 152A and 152B (having lumens 151A and 151B) joined together byan exterior polymer film wrap 154. Positioned within the void spacebetween the tubular elements is a solid tubular element 162. Tubularelement 162 can be for example a guidewire or a stiffening stylet.Tubular element 162 can be free to translate longitudinally within thevoid space lumen or may be fixed to the catheter assembly by adhesivesor by frictional interference. Polymer film 154 may be puncturable bythe end of the guidewire to allow a physician to choose a suitableguidewire exit port at virtually any point along the length of thecatheter, if desired.

Moreover, polymer film wrapping can be used to form catheters havingsimilar profiles as those shown in FIGS. 2B through 2F. For example,shown in FIG. 8C is a general catheter 150 formed from a first tubularelement 152 having lumen 151A, a second “skived” tubular element 164having lumen 151B and a polymer film wrap 154. The polymer film wrap 154is in contact with an exterior surface 158A and 158B of both tubularelements 152 and 164 respectively. Tubular elements having essentiallyunsupported or collapsible profiles (such as element 164) can besupported, for example, by a mandrel during polymer film wrapping orduring subsequent processing. Lumen 151 b can be a guidewire lumen,wherein polymer film wrap 154 can be easily punctured by a guidewireend, as discussed above, to allow a physician to choose a guidewire exitport along the length of the catheter.

A further aspect of the present invention is depicted in FIG. 8D. Shownis a general catheter 150 formed from a first, hollow tubular element152 having lumen 151, a second tubular element 162 and a polymer filmwrap 154. The polymer film wrap 154 is in contact with exterior surfaces158A and 158B of both tubular elements 152 and 162. Tubular element 162can be free to translate longitudinally within the void space lumen(e.g., to function as a guide wire) or may be fixed to the catheterassembly by adhesives or by frictional interference (e.g., to functionas a stiffening stylet). Polymer film wrap 154 may be puncturable by theend of a guidewire to allow a physician to choose a suitable guidewireexit port along the length of the catheter.

Shown in FIG. 8E is a cross-sectional profile of a general catheter 150of the present invention formed from a first tubular element 152 havinglumen 151A, a second “D-shaped” tubular element 166 having lumen 151Band polymer film wrap 154. The polymer film wrap 154 is in contact withexterior surfaces 158A and 158B of both tubular elements 152 and 166.

Shown in FIG. 8F is a cross-sectional profile of a general catheter 150of the present invention formed from first, second and third tubularelements 152A, 152B, and 152C (having lumens 151A, 151B, and 151C) andpolymer film wrap 154. The polymer film wrap 154 is in contact withexterior surfaces 158A, 158B, and 158C of all three tubular elements152A, 152B, and 152C. Also shown in FIG. 8F is a circular or smoothluminal surface 168, a “non-smooth”, fluted luminal surface 170 andthree void spaces 172. A void space 172 can be optionally used as afluid communication path or guidewire lumen along at least a portion ofa length of a general catheter 150.

In a further aspect, an exterior polymer film wrap can be used tosecure, provide strain relief or join tubular elements together to formvarious catheter constructions. Shown for example in partialcross-sectional view FIG. 9A is a first longitudinally extending tubularelement 152A having a through lumen 174A, an exterior outer surface 158Aand a distal region 176. Also shown is a second longitudinally extendingtubular element 152B having a through lumen 174B, an exterior outersurface 158B and a proximal region 178. The distal region 176 of thefirst tubular element 152A is in contact with or joined to the proximalregion 178 of the second tubular element 152B in an abuttingrelationship wherein the lumen 174A is in fluid communication with thelumen 174B. An external polymer film at least partially covers and is incontact with the outer surfaces 158A and 158B of both tubular elements152A and 152B along the joined region. The polymer film 154 can providea strain relief to enhance the flexural and fatigue properties of thejoined tubular elements. Further, it can be designed to increase burststrength or tensile strength without significantly changing flexibilityof the catheter. Moreover, the two tubular elements can be adheredtogether using adhesives, fuse bonding, melt bonding, or other suitablemeans in addition to providing the polymer film. The polymer film layer154 may also serve as a “fail-safe,” should an underlying bond fail.Polymer film can be selected so that the polymer film tensile strengthis many times that of the catheter components or the bond zone strength.The polymer film is preferably wrapped about the two tubular members,using one of the techniques described above. Moreover, either or both ofthe tubular elements can be provided with further lumens, which can alsobe in fluid communication with a corresponding lumen in the othertubular element. For example, each of the first tubular element 152A andthe second tubular element 152B can be provided with a first throughlumen and a second through lumen. The first through lumen of eachelement can be in fluid communication with each other and the secondthrough lumen of each element can be in fluid communication with eachother. The first through lumens can be sized to accept a guidewire in asliding relationship and the second through lumens can be sized todeliver inflation fluid to an expandable member located on the distalend of the catheter, or to deliver any number of devices, medications,etc., to a treatment site.

In an alternate configuration, tubular elements can be similarly joinedtogether in an overlapping relationship. Shown in partialcross-sectional view, FIG. 9B is a first longitudinally extendingtubular element 152A having a through lumen 174A, an exterior outersurface 158A and a distal region 176. Also shown is a secondlongitudinally extending tubular element 152B having a through lumen174B, an exterior outer surface 158B and a proximal region 178. Thedistal region 176 of the first tubular element 152A overlaps theproximal region 178 of the second tubular element 152B. An externalpolymer film 154 at least partially covers and is in contact with theouter surfaces 158A and 158B of both tubular elements 152A and 152Balong the joined region. The polymer film layer 154 can provide a strainrelief to enhance the flexural and fatigue properties of the overlappingtubular elements. Further, it can be designed to increase burst strengthor tensile strength without significantly changing flexibility of thecatheter. Moreover, the two tubular elements can be adhered togetherusing adhesives, melt bonding, or other suitable means in addition toproviding the polymer film. The polymer film layer 154 may also serve asa “fail-safe,” should an underlying bond fail. Polymer film can beselected so that the polymer film tensile strength is many times that ofthe catheter components or the bond zone strength. The polymer film ispreferably wrapped about the two tubular members, using one of thetechniques described above.

Shown in FIG. 9C are two tubular elements joined in a skived or lapjoint configuration. Shown is a first longitudinally extending tubularelement 152A having a through lumen 174A, an exterior outer surface 158Aand a distal region 176. Also shown is a second longitudinally extendingtubular element 152B having a through lumen 174B, an exterior outersurface 158B and a proximal region 178. The distal region 176 of thefirst tubular element 152A is in contact with or joined to the proximalregion 178 of the second tubular element 152B. An external polymer filmat least partially covers and is in contact with the outer surfaces 158Aand 158B of both tubular elements 152A and 152B within the joinedregion. The polymer film 154 provides a strain relief to enhance theflexural and fatigue properties along the lap joint. Moreover, the twotubular elements can be adhered together using adhesives, fuse bonding,melt bonding, or other suitable means in addition to providing thepolymer film. The polymer film is preferably wrapped about the twotubular members, using one of the techniques described above.

A film wrapped external layer can be used to secure individualcomponents onto a tubular member to form catheters of the presentinvention. Shown for example in partial cross-sectional view, FIG. 10shows a first longitudinally extending tubular element 152A having anouter surface 158 and a lumen 174A. A balloon or second element 180 isin contact with the outer surface 158 of the distal section of the firsttubular element 152A. A polymer film 154 is shown in contact with theouter surface 158 of the distal section of the first tubular element152A and in contact with the outer surface of the distal section ofballoon 180. Also shown is a third element or longitudinally extendingtube 152B having a lumen 174B. Polymer film 154 is shown in contact withthe outer surface of the proximal section of the balloon 180. Preferablypolymer film 154 is wrapped about the outer surface of the proximalsection of the balloon 180. Polymer film 154 can also be in contact withthe outer surfaces of first tubular element 152A and third element 152Bat sections proximal to balloon 180. Polymer film 154 can also extendfrom the balloon 180 to the proximal end of the catheter 150, or to anypoint proximal to the balloon 180. The lumen 174A of firstlongitudinally extending tubular element 152A is configured as aguidewire lumen having a distal guidewire exit port 175 and the lumen174B of the third element 152B is configured as an inflation lumen withits distal end terminating in the interior of the balloon 180. Moreover,first tubular element 152A can be the length of the catheter and have aproximal guidewire exit port (not shown), as well as any number ofguidewire exit ports located distal to the proximal end of the catheterand proximal to the proximal end of balloon 180. Of course, firsttubular element 152A may also terminate at a point distal to theproximal end of the catheter, thus being configured as the well knownrapid exchange type catheter. The balloon 180 can be any suitableconstruction. For example, the balloon 180 can be formed by filmwrapping that, in addition to forming a balloon, is used to secure twoor more tubular elements together in a fashion depicted in FIGS. 7A-Dand 8A-F. Moreover, the distal end of inner surfaces of the balloon 180can be sealed to the outer surface 158 of first tubular element 152A,and the inner surfaces of the proximal end of balloon 180 can be sealedto the outer surfaces of the first tubular element 152A and thirdelement 152B by any suitable means, such as by adhesives, fuse bonding,heat bonding, etc. Polymer film 154 can then be provided to (preferablywrapped about) at least one of the distal end and the proximal end ofthe balloon 180, to, for example, further secure the balloon 180 to thecatheter.

In addition to securing multiple tubular elements or balloons, polymerfilm can be used to secure or cover various secondary components to formcatheters of the present invention. These secondary components orelements include but are not limited to radiopaque elements,visualization elements (such as indicia), radioactive elements, chemicaleluting elements, electrical components, valves, seals, occluders,filters, membranes, members used to alter or enhance mechanicalproperties, historic indicators of use, temperature or sterilization,fluid fittings and interconnect hubs. Shown for example in partialcross-sectional view, FIG. 11 shows a first longitudinally extendingtube 152A having an outer surface 158 and a lumen 174. A second element,in this case radiopaque marker bands 182, are in contact with the outersurface 158 of the first tubular element 152A. A polymer film 154 isshown in contact with the outer surface 158 of the first tubular element152A covering the second elements 182. Also shown is a visualizationmarking or label 184 that is in contact with the outer surface of thefirst tubular element 152A. The visualization marking or label (i.e;indicia) 184 is covered by a polymer film 154 that is in contact withthe marking 184 and the outer surface 158 of the first tubular member.Transparent or opaque polymer films can be used to secure or covervarious secondary components. Other secondary elements can be covered orsecured by film layers by constructions similar to those depicted inFIGS. 10 and 11.

Film wrapping processes can be used to construct an entire catheter tubeor be used to modify the properties of a catheter tube from a proximalpoint to a distal point on the tube. The same polymer materialsdiscussed above are suitable for this aspect of the invention as well.Shown for example in partial cross-sectional view in FIG. 12 are threecross-sectional regions 186, 188 and 190 of a single general catheter150. The three regions can have different physical properties due to thedifferent film wraps applied to each region. Shown in cross-sectionalregion 186 is an elongated tubular element 152 having a single filmlayer 154 wrapped about the tubular element. Similarly shown incross-sectional region 188 is an elongated tubular element 152 havingfour individual film layers 154A, 154B, 154C and 154D wrapped about thetubular element. Also shown in cross-sectional region 190 is anelongated tubular element 152 having six individual film layers 154A,154B, 154C, 154D, 154E and 154F wrapped about the tubular element. Eachregion can be tailored, by altering the individual film layers, to havedesired mechanical characteristics such as flexibility, column orcompression strength, tensile strength, crush resistance, burststrength, wall thickness, torsional strength, lubricity, etc. Thesedifferent mechanical properties can be controlled by varying the numberof film layers, by varying the film wrap pattern or by varyingindividual film properties such as film material, film thickness, filmstrength or film orientation. A general catheter according to thisaspect of the invention can have, for example, a relatively stiffproximal region transitioning to an intermediately stiff transitionregion that transitions to a relatively flexible distal region.Furthermore, polymer film can be wrapped about a catheter in discreetlocations to be located near both ends of an implantable device, such asan expandable stent, to constrain the device and/or prevent longitudinalexpansion of, for example, the stent. Moreover, the polymer film couldbe wrapped in a layered manner to provide a smooth transition from theouter surface of the catheter to the stent on either side of the stent.Catheter tubes according to this aspect of the invention can beconstructed entirely from film wrappings or can be formed by wrappingfilm about any elongated tubular structure, such as a polymer extrusion,hypotube, etc.

Catheters can be constructed having physical attributes that vary bydistinct regions or can display a progressive or continuous gradient inphysical properties. Shown for example in partial cross-section viewFIG. 13 is a general catheter 150 having a first end region 192 and asecond end region 194. The first end region 192 has a wall thickness 196that is less than the wall thickness 198 of the second end region 194.In addition, the first end region 192 has a inner dimension 200 that isgreater than the inner dimension 202 of the second end region 194. Suchdimensions can be altered by progressively varying the number of filmlayers, by progressively varying the film wrap pattern or byprogressively varying individual film properties (such as thickness)along the length of the catheter. In an alternate embodiment, cathetersof the present invention can have variable properties by discrete or“step” variance in the film application. Furthermore, catheters can beformed having essentially constant inner diameters (IDs), outerdiameters (ODs), and/or wall thickness, but longitudinal properties canbe varied by using different film materials over the length of thecatheter.

Film wrapping processes are ideally suited for forming tubular elementswith “non-linear” profiles such as tapers, flares, an “egg in a snake”bulge, square to round (profile 1 to profile 2) shapes, large to smalldiameters or any other, “generally non-extrudable” profile. Shown forexample in partial cross-sectional FIG. 14 is a general catheter 150 ofthe present invention having a first end region 192 and a second endregion 194. The first end region 192 has a inner dimension 200 that isgreater than the inner dimension 202 of the second end region 194. Thegeneral catheter has a wall thickness 204 that is essentially uniformalong the longitudinal length.

Catheter profiles, such as the tapered profiles shown in FIGS. 13 and 14can be constructed by film wrapping over a tapered or non-linearmandrel. Preferably, the film is an expanded fluoropolymer (e.g., ePTFE)that has a thermoplastic coating (e.g., FEP) applied to an externalsurface of the film. The film can be wrapped about the mandrel with thethermoplastic coating facing outwards. The thermoplastic coating can bemelted to adhere the film wrap together on the outside surface, leavingan inner, lubricious surface on the inner surface of the cathetercomponent. The catheter component can then be removed from the mandrel.One skilled in the art will now understand the various catheterconfigurations which can be constructed using this film wrappingprocedure. One advantage to using this procedure is the ability toeasily construct tubular elements with incredibly tight wall thicknesstolerances, as compared to forming tubular elements by an extrusionprocess. Polymer films—particularly ePTFE films—can be produced inextremely thin films with very little thickness variance across thefilm. Thus, by wrapping such a film about a mandrel, tubes with tightlycontrolled wall thicknesses can be easily produced. Moreover, tubeconcentricity can also be easily and tightly controlled using such afilm wrap process.

Film wrapping processes can also be used to form tubular members thathave a longitudinal sliding relationship. For example as shown inpartial cross-sectional view FIG. 15A is a general catheter 150 of thepresent invention having a longitudinally extending tubular element 152with a film wrapped external layer 154. In an aspect of the invention,the film 154 is an expanded fluoropolymer (e.g., ePTFE) and has athermoplastic coating (for example FEP) applied to an external surfaceof the film. Thus the film can be wrapped over the tubular element 152with the thermoplastic coating facing outwards. The thermoplasticcoating can be melted to adhere the film wrap together on the outsidesurface leaving an inner lubricious surface (the expanded fluoropolymer)that does not adhere to the longitudinally extending tubular element152. Since the film covering 154 is not adhered to the tubular element152 the two components can be free to move longitudinally relative toeach other. In addition a sealed or “zero-clearance” fit between thetube and the film can be produced by the film wrap. Shown in FIGS. 15Band 15C are examples of such a sliding fit between a base tube 152 andan external film wrap 154. Shown are longitudinal relative motions 206between the base tube 152 and the external film wrap 154.

In a preferred embodiment, a general catheter of the present inventionhas a longitudinally sliding fit between a base tube and an externalfilm layer that forms a sliding “gate-valve”. Shown in partialcross-sectional view FIG. 16A is a general catheter of the presentinvention 150 having a longitudinally extending tubular element 152covered by a film layer 154. The longitudinally extending tubularelement 152 has a first port 208 and the film layer 154 has a secondport 210. The ports are shown in a longitudinally separated position, sothat the valve is “closed”.

Shown in partial cross-sectional view FIG. 16B is a general catheter ofthe present invention 150 having a longitudinally extending tubularelement 152 covered by a film layer 154. The longitudinally extendingtubular element 152 has a first port 208 and the film layer 154 has asecond port 210. When the tubular element 152 is longitudinallytranslated 206, the ports 208 and 210 become aligned as shown, so thatthe valve is “opened”. Of course, each of the tubular element 152 andthe film layer 154 can be provided with more than one port.

FIG. 17 is a partial cross-sectional view of a general catheter 150 ofthe present invention having a spiral cut tube (such as a polymer tube,metal tube such as a hypotube, etc.) 212 wrapped with a film layer 154.The gaps or cuts 214 in the tube are essentially sealed by the film wrap154. The desired flexibility of the tube is maintained and by theaddition of the film wrap 154, a sealed fluid lumen is formed within thetube. Such constructions are suitable for forming ports or “hydro-jets”into the tube. Shown in partial isometric view, FIG. 18A is a tube 212having a spiral cut 214. The tube is covered with a film layer 154 thathas gaps 216 between the adjacent film edges. The gaps 216 in the filmlayer in effect form fluid ports or hydro-jets that coincide withselected gaps in the cut tube. In an alternate embodiment shown inpartial cross-sectional view FIG. 18B the tube 212 is fully covered by afilm wrapped layer 154 similar to that shown in FIG. 17. The film layercan have cut holes or ports 218 that align with selected gaps 214 of thetube, or holes 218 can be cut through the tube to form a port orhydro-jet. Moreover, the tube can be provided with a spiral cut withchanging pitch across all, or a part of, the length of the tube, thusproviding a flexibility transition region in the tube. Of course,desirable flexible tubing can be obtained by other means than providinga spiral cut tube. In this regard any tubular element having at leastone fenestration through its wall may be used. Suitable fenestrationscan be obtained by, for example, etching, cutting, drilling, etc. Anydesirable number of fenestrations can be provided. For example,strategically placed cuts could be located at any number of locationsalong the length and/or around the circumference of the tube. The cutsin the tubing could be strategically arranged to provide for varyingflexibility across the length of any number of tubular bodies. Just asdiscussed above, the cuts in the tube would be suitable for formingports for “hydro-jets”. Furthermore, rather than using a cut tube, aspiral metal ribbon could be wrapped with a film layer 154.

With regard to film wrapping of fenestrated tubing, it is believed thatan ePTFE/adhesive laminate film may be particularly useful. For example,as discussed above, it may desirable to provide an adhesive to the outersurface, the inner surface, or both, of the ePTFE film to provide forenhanced properties. In such a case, it is believed that the ePTFE isparticularly attractive, since the ePTFE may act as a stable scaffold(i.e., the film tends to shrink only a small amount) for the adhesive.For example, when wrapping a metal hypotube with an ePTFE/FEP system,the FEP could act as an adhesive, the system could be heated to causethe FEP to flow; however, the FEP will tend to stay in the ePTFEstructure and not infiltrate into the fenestrations in the hypotube.Further embodiments could include wrapping a cut PEBAX tube with anePTFE film and an adhesive with a lower melting temperature—or indeed aUV curable adhesive. Other variations of this embodiment will now beapparent to the skilled artisan.

Film coverings of the present invention do not necessarily have to beadhered or fixed onto a base tubular element. In some preferredembodiments, catheters of the present invention can have film coveringsthat are non-adhered or separate from the underlying base tubularelement. Shown for example in partial cross-sectional view FIG. 19A is ageneral catheter 150 of the present invention having a longitudinallyextending tubular element 152 (which can have at least one lumenextending for at least a portion of its length, or can be a solidstructure, such as a guidewire) covered with a “relaxed” non-distendingfilm 220. The non-distending film covering 220 is shown having generallysinusoidal folds 222. The non-distendable film covering 220 can have anysuitable relaxed or non-expanded shape having for example folds,corrugations or pleats which can be oriented circumferentially orlongitudinally. The non-distending film covering 220 is shown in contactwith portions of external surface 158 of the tubular element 152. Thefilm covering 220 is not adhered to the depicted portion of thelongitudinally extending tubular element 152. As shown in partialcross-sectional view FIG. 19B, when an inflation fluid or gas isinjected into the interstitial space 224, the non-distending filmcovering 220 unfolds and expands to form a fluid communication pathbetween the film covering 220 and the longitudinally extending tubularelement 152. Inflation fluid or gas can be injected into theinterstitial space 224, for example, via a port located on or near theproximal end of the catheter, or when tubular element 152 has a lumen,the tubular element 152 can be provided with perforations, apertures,etc., through the tube wall and the fluid or gas can be injected intothe lumen through the perforations, apertures, etc., to unfold andexpand the film covering.

In a similar configuration, stretchable, elastic or distending filmcoverings can be applied and selectively non-adhered to a longitudinallyextending tubular element. Shown for example in partial cross-sectionalview FIG. 20A is a general catheter 150 of the present invention havinga longitudinally extending tubular element 152 (which can have at leastone lumen extending for at least a portion of its length, or can be asolid structure, such as a guidewire) covered with an elastic,stretchable film 226. The stretchable film covering 226 is shown incontact with (but non-adhered-to) an external surface 158 of the tubularelement 152. As shown in partial cross-sectional view in FIG. 20B, whenan inflation fluid or gas is injected into the interstitial space 224(as discussed above), the film covering 226 stretches and expands toform a fluid communication path between the film covering 226 and thelongitudinally extending tubular element 152. A film can be rendered“stretchable”, for example, by applying an elastic material to the filmwhile in a compressed state or by applying a film wrap having anexpandable pattern similar to a “Chinese Finger Grip” configuration.

Alternate uses of film wrappings on catheters include the sealing ofsecondary lumens or channels. Shown for example in cross-sectional viewFIG. 21 is a typical catheter section modified according to an aspect ofthe present invention. Shown is optional inner lubricious (e.g., PTFE)liner 228 defining a generally centrally located lumen 231, which canextend for at least a portion of the length of the catheter body or forthe entire length of the catheter body. The PTFE liner 228 can beformed, for example, as an extruded tube of PTFE, or from PTFE tape(e.g., ePTFE tape) which has been formed into tubular shape by wrappingthe tape about a mandrel, as discussed above. Also shown is an optionalcircumferentially and longitudinally extending wire support braid 230embedded into a thermoplastic layer 232. In an aspect of the inventionthermoplastic layer 232 is provided without the wire support braid. Alaser (such as a 20 watt CO² laser, Applied Laser Technology, Beaverton,Oreg.) can be used to selectively cut a longitudinal (or spirally)extending channel 234 of virtually any desired shape in thethermoplastic layer 232. The channel can extend for at least a portionof the length of the catheter body or for the entire length of thecatheter body. The laser power can be adjusted to remove thethermoplastic 232 but not the PTFE inner liner 228 or the optional wiresupport braid 230. Film 154 can then be applied to the exterior surface158 of the catheter, forming a fluid communication path 236 or lumen inthe existing wall of the catheter. The film 154 can be provided to coverthe channel and only portions of the thermoplastic layer near thechannel so as to form a fluid communication path 236 in the catheter, orthe film 154 can be wrapped about the circumference of the catheter,thus forming a fluid communication path 236 in the catheter.

In a further aspect of the invention, demonstrated in FIG. 21A, thecatheter can have a proximal end and a distal end, with a generallycentrally located lumen 231 extending from its proximal end to itsdistal end. The longitudinally (or spirally) extending channel 236extends from the catheter proximal end (or near its proximal end) to itsdistal end (or near its distal end) where it can be in fluidcommunication with the interior of an inflatable member 301 located onthe distal end of the catheter. Inflation fluid can be delivered to, andremoved from, the interior of inflatable member 301 through channel 231as shown by arrows 302. Inflatable member 301 can be, for example, anocclusion balloon designed to occlude blood flow in a target vessel orartery 400, while still allowing blood to flow through the generallycentrally located lumen 231 of the catheter. Generally centrally locatedlumen 231 can also be used to advance a guidewire (or other desirabledevice such as a dilatation catheter, thrombectomy removal device,treatment catheter, embolic filter, medication, etc.) through thecatheter to aid in guiding the catheter to a treatment site. Use of thewire support braid 230 may allow for construction of a catheter of thistype with extremely small profiles, due to the extra support provided bythe wire braid in combination with the ability to form, for example, afluid delivery lumen (i.e. the channel) of extremely small crosssection. Thus, the catheter of this aspect of the invention may beparticularly attractive for use in treatments in the cerebralvasculature of a patient. Furthermore, the catheter according to thisaspect of the invention could be constructed so that a dilatationballoon is located on the distal end of the catheter. Fluidcommunication path can be in fluid communication with the interior ofthe dilatation balloon, thus allowing for the delivery and removal ofinflation fluid to the dilatation balloon. Generally centrally locatedlumen 231 could be sized to accept in a sliding relationship aguidewire. Of course, an expandable stent could be mounted on thedilatation balloon.

Film wrapping processes can also be used to alter or create new surfaceprofiles on tubular elements. Shown for example in partial isometricview, FIG. 22A is a catheter section 150 comprising a longitudinallyextending tubular element (which may contain a lumen extending for atleast a portion of its length) 152 having a selectively adhered filmcovering 238 that is in contact with the exterior surface 158 of thetubular element 152. The film 238 has portions that are adhered 240 tothe tubular element 152 and portions that are not adhered 242, forming acontinuous spiral array of “fish scales”. Such fish scales can be usedto impart directional friction (e.g., within a blood vessel or artery)so that a catheter of the present invention resists longitudinal motionin one direction yet slides easily in the opposite direction. Fishscales or “sails” can also be used to “catch” a fluid flow (e.g., bloodflow) and allow a catheter to be carried along with the fluid flow, orat least aid in advancing the catheter. Films can be selectively coatedwith an adhesive or thermoplastic, for example, on one edge to formscales or other surface modifications according to the presentinvention. Films fully coated with an adhesive or thermoplastic can bewrapped over a temporary intermediate layer of a high temperaturematerial that prevents portions of the film from adhering to itself.

FIGS. 22B and 22C show in partial isometric and in partial cross-sectionrespectively a catheter section 150 according to this aspect of theinvention. As shown in FIGS. 22B and 22C, the film 238 is shown layingagainst the exterior surface 158 of the tubular element 152. Ghost lines241 in FIG. 22B indicate the portions of the film that are adhered tothe exterior Surface 158 of the tubular element 152. Moreover, FIG. 22Ddemonstrates use of a catheter according to this aspect of the inventionas, for example, a dilatation balloon catheter. As seen in FIG. 22D,catheter 150 is shown being advanced to place expandable member 301across a stenosis S. The arrows indicate the direction of blood flowwithin a patient's blood vessel or artery. As shown, selectively adheredfilm covering 238 is now in contact with the exterior surface 158 of thetubular element 152 at only those portions where the film 238 has beenadhered 240 to the tubular element 152, thus forming a continuous spiralarray of “fish scales”. As should now be apparent, the continuous spiralarray of fish scales, which also resemble an auger formation, canassist, and perhaps indeed direct, the catheter 150 to advance distallyin a chosen blood vessel or artery. Moreover, it should be apparent thatby providing a rotational force to the catheter 150, further ease ofadvancement is obtainable. Furthermore, by applying rotational force, itmay be possible to help increase the blood flow in patient's artery orvessel. It should be noted that the film forming the spiral array offish scales need not be provided as a continuous strip of film. Asshould now be appreciated, the selectively adhered film covering mayalso have benefits when the catheter is fixed, relative to the directionof blood flow. As shown in FIG. 22D, if blood flow is in the directionof the arrows, the film may act to disrupt or obstruct blood flow in avessel. If blood flow is in a direction opposite the arrows, the bloodflow may push the film against the outer surface 158 of the catheter150; thus the film will not significantly interfere with blood flow inthis direction.

In an alternative embodiment, suitable “fish scales” or “sails” could beobtained by using polymer film having a variable stiffness or thicknessacross the width of the film. For example, a suitable polymer film couldbe cut into tape form wherein one side of the tape is thicker than theother side of the tape. As shown in FIG. 22E, the polymer film tape 238could then be located on the exterior surface 158 of a tubular element152, with the thicker side of the tape 238 a closer to the proximal endof the tubular element 152. Like the other embodiments, the tape couldbe arranged in a continuous manner about the tubular element, or in anydesired discontinuous manner. The thicker sides of the tape could servethe same function as the “fish scales” and “sails” discussed above. Thesurface of polymer film tape 238 in contact with the exterior surface158 of the tubular element 152 can be, if desired, either completelyadhered to the exterior surface or adhered in only selected portions ofthe film area in contact with the exterior surface 158.

Still further aspects of the invention include wire-based guidewires,catheters and micro-catheters having profiles suitable for advancementinto a patient's cerebral vasculature. Such wire-based devices cancomprise at least one longitudinally extending wire having a length andat least an outer surface with at least one cut therein, a proximal end,and a distal end. The wire-based device further comprises polymer filmcovering at least a portion of the outer surface of the at least onewire, and a therapeutic and/or diagnostic device, located at the distalend of the wire-based device.

In an aspect of the invention, the polymer film is provided as a polymerfilm wrap. In a further aspect of the invention, the polymer film can beprovided as a tubular shrink wrap. With regard to the polymer film wrap,in an aspect of the invention, the polymer film wrap is provided as ahelical wrap, as discussed above. Moreover, in an aspect of theinvention, the polymer film wrap comprises ePTFE, as discussed above. Ina further aspect of the invention, the therapeutic device can beselected from the group consisting of expandable balloons (e.g., eitherdilatation balloons or occlusion balloons), stents, stent-grafts,energy-emitting devices, and fiber-optic devices. In an aspect of theinvention, the stents and or stent-grafts can be self-expanding.Moreover, in a further aspect of the invention, the stent or stent-graftcan be mounted over an expandable balloon.

The at least one longitudinally extending wire can comprise, forexample, metal wire, polymer or metal tubing (such as stainless steelhypo tube), etc. The wire can further include an inner surface definingat least one lumen extending for at least a portion of the wire length.The at least one lumen can extend from the proximal end to a pointproximal to the distal end or to the distal end of the wire.Furthermore, it may be desirable to provide at least a portion of theinner surface of the wire with a polymer covering (e.g., a polymer filmcovering).

In an aspect of the invention, an expandable balloon is located near thedistal end of the wire and the wire lumen extends from the proximal endto near the distal end of the wire and is in fluid communication withthe interior of the expandable balloon.

When the wire comprises a hypo tube, it may be desirable for the atleast one cut to extend from the outer surface to the inner surface ofthe hypo tube (i.e., completely through the wall of the tube). Moreover,the at least one cut may be a spirally extending cut extending for anydesirable length of the hypo tube. In an aspect of the invention, thespirally extending cut can extend from the proximal end to the distalend of the hypo tube. Moreover, the pitch of the spiral cut can bevaried from one point to another along the length of the tube to varythe flexibility of the tube over a desired length.

Moreover, in an aspect of the invention, the at least one cut, forexample the spirally extending cut forms a spirally extending channel inthe wire surface. The spirally extending channel can extend for anydesired length of the wire and can be of varied pitch (or a constantpitch) from one point to another. In an aspect of the invention, thespirally extending channel can extend from the proximal end of the wireto near (or completely to) the distal end of the wire. The channel canthen be covered with polymer film, thus forming a spirally extendinglumen in the wire. The wire of this aspect of the invention can be asolid wire, or it can comprise a generally centrally extending lumendefined by an inner surface of the wire (e.g., the wire can be ahypotube). When the wire comprises a centrally extending lumen definedby an inner surface of the wire, the spirally extending cut does notextend through the inner surface of the wire. The spirally extendinglumen can be in communication with the interior of an expandable balloonlocated near the distal end of the wire. Thus inflation fluid can bedelivered to the balloon interior via the lumen.

It is also possible to provide at least one radiopaque material to thedevice. The radiopaque material can be any suitable material and can belocated at any desired point along the length of the device.

When a self-expanding stent or stent-graft is provided, the stent orstent-graft may be held in a compressed state by a sheath (or othersuitable constraining device) located over the stent or stent-graft. Insuch an embodiment, the device may further comprise a deployment lineextending from a port at the proximal end of the device through thelumen, exiting the lumen at a point proximal to the sheath through aport formed through the wire, and connected to the sheath. Theself-expanding stent or stent-graft may then be deployed by thephysician once located at the desired treatment site. Moreover, in suchan embodiment it may be desirable to further provide an expandableballoon at or near the distal end of the wire, the balloon having aninterior, wherein the interior is in fluid communication with the lumen.

The device may further comprise a stiffening device, which may belocated in the at least one lumen. In an aspect of the invention, thestiffening device is capable of being moved proximally and distally inthe at least one lumen. Suitable stiffening devices include, forexample, stylets, wires, tubes, braids, and combinations thereof. Thestiffening device may be solid or hollow. Moreover, the stiffeningdevice can have a variable stiffness along at least a portion of itslength. Further, the stiffening device may comprise any suitablematerial, such as, metal, metalloids, and polymers.

It should be noted that the inner surface or the outer surface of thewire can be pretreated (i.e., chemically etched, etc.) prior toproviding the polymer film or covering to the surface.

It should be understood that due to the combination of the polymer filmand wire it is possible to construct wire based devices having extremelysmall profiles, the device being sufficiently flexible, yet includingthe necessary pushability and maneuverability to be advanced deep into apatient's cerebral vasculature. Moreover, the wire catheter can alsoserve as a guidewire wherein a further device can be advanced over thewire catheter to provide at least one additional therapeutic device to atreatment site.

Several exemplary embodiments (and uses therefore) of theabove-described wire-based device will now be discussed. Each of thebelow embodiments can comprise any of the features of theabove-described wire-based device.

Turning to FIG. 23, one exemplary embodiment utilizing two wire-baseddevices discussed above and according to the invention is shown. Shownis elongated tube 400 having a generally centrally located lumen whereintwo wire-based devices 401 and 402 are slideably located. Eachwire-based device comprises a balloon-on-a-wire device having anelongated wire having a length, an outer surface having at least one cuttherein, polymer film 403 and 404 covering at least a portion of theouter surface, a proximal end and a distal end, and a first expandableballoon 405 and 406 near each wire distal end. Expandable balloons 405and 406 can be either dilatation balloons or occlusion balloons.Moreover, expandable stents may be mounted over the balloons as desired.Each wire-based device further comprises atraumatic tip 407 and 408,such as a coil. Each wire-based device further includes an inflationlumen extending for at least a portion of the length of the elongatedwire and in communication with the interior of the expandable balloonlocated at the wire distal end. The wire-based devices are in a slidingrelationship with each other and with the centrally located lumen of theelongated tube 400.

The embodiment shown in FIG. 23 is particularly useful for treatingbifurcations where the elongated tube 400 can be advanced to a pointproximal to the target bifurcation and then each wire-based device 402and 403 advanced into the desired treatment vessel distal to thebifurcation. For example, the distal end of the elongated tube 400 canbe advanced into a patient's common carotid artery, just proximal to thebifurcation leading to the internal carotid artery and the externalcarotid artery. Wire-based device 402 can then be advanced into theinternal carotid artery and wire-based device 403 can then be advancedinto the external carotid artery. Artery occlusion, dilatation, and/orstent placement can then be carried out. Moreover, the elongated tubecan be sized to be advanced distally into the patient's internal carotidartery to treat locations distal thereto. Thus, this embodiment allowsthe practitioner to keep both wire-based device (or one wire-baseddevice) in the elongated tube 400 until the target region is reached,thus eliminating the possibility of the wires getting crossed (a problemif the wire-based devices are advanced separately, or without anelongated tube).

Elongated tube 400 can further comprise an expandable member, such as anexpandable balloon, located at the distal end of the elongated tube 400.An inflation lumen extending for a portion of or the entire length ofthe tube and in communication with the balloon interior can also beprovided.

Elongated tube 400 can include an at least partial coating of alubricious material on at least one of the tube outer surface or lumensurface. Such a coating can extend for a portion of or the entire lengthof the tube. The elongated tube 400 can comprise any suitable material,such as metals and plastics. In an aspect of the invention the tube 400is a plastic extrusion. In a further aspect of the invention, theelongated tube can comprise polymer wrapped film. The elongated tube 400preferably has a length that is less than the length of at least one ofthe balloon-on-a-wire devices, more preferably a length less than bothof the balloon-on-a-wire devices. In a further aspect of the inventionthe elongated tube 400 comprises an adjustable length. The tube lengthcan be made adjustable by providing at least a portion of the tube witha scrunchable section, as defined above.

The elongated tube 400 preferably has an outer diameter of about 1.25mm.

Moreover, the embodiment shown in FIG. 23 can further comprise acatheter having a lumen extending for at least a portion of the lengthof the catheter, and preferably, for the entire length of the catheter.The elongated tube 400 can be locatable within the catheter lumen, in asliding relationship. The catheter can have an inflatable member at itsdistal end.

Turning now to FIG. 24 there is shown in schematic cross-section afurther aspect of the wire-based device according to the invention.Shown is a balloon-on-a-wire device further including a self-expandingstent located near the distal end thereof. As shown, the device 500includes wire catheter 501 having a generally centrally located lumen502 extending from the wire proximal end (or near its proximal end) tonear the wire distal end and in communication with the interior ofexpandable balloon 506. The device also includes atraumatic tip 507attached to the distal end of the wire catheter 501. Located proximal toexpandable balloon 506 is self-expanding stent 504 (although shownlocated proximal to the expandable balloon 506, the stent 504 could alsobe located distal to the expandable balloon, or two stents could beprovided, one distal to and one proximal to the expandable balloon).Self-expanding stent is held in a compressed state by stent containmentmember 503. Stent containment member 503 can cover a portion of, or theentire length of, the stent 504. In an aspect of the invention stentcontainment member 503 comprises a longitudinally extending sheath.Attached to the proximal end of the stent containment member 503 isdeployment mechanism 505 (such as a deployment line). Deploymentmechanism 505 extends proximally to the proximal end of the device whereit can be withdrawn proximally, either by hand or use of a suitablemechanical device. Deployment mechanism 505 can extend along the outersurface of the wire catheter and then, at any desired point along thelength of the wire, extend through an opening in the wall of the wire,into the generally central lumen of the wire. The polymer film covering(discussed above) can cover the opening and provide a tight seal betweenthe polymer film and the deployment mechanism 505. In such an embodimentthe generally centrally located lumen 502 can then serve a dualfunction. That is, the lumen 502 can serve as an inflation lumen, beingin communication with the interior of the expandable balloon 506, andalso serve as a lumen for the deployment line. With judicious selectionof polymer film covering and wire catheter material (such as ePTFE andmetal hypo-tube, respectively) the film can provide a seal between thecatheter wall and the deployment line to prevent balloon inflation fluidfrom escaping the lumen, but still allowing the deployment line to beretracted proximally along the device.

In a further aspect of the invention the device can comprise at least asecond lumen, wherein the first lumen accepts the deployment member 505in sliding relationship and the second lumen is in communication withthe interior space of the expandable balloon 506.

Operation of the device should now be apparent. The device can beadvanced to the desired treatment site and expandable balloon 506 (whichcan be either an occlusion or dilatation balloon) inflated. Deploymentmechanism 505 can then be retracted to withdraw stent containment member503 to allow self-expanding stent 504 to expand. Thereafter, expandableballoon 506 can be deflated and the device withdrawn.

Turning now to FIG. 25, still a further embodiment of theballoon-on-a-wire device of the invention is shown. Shown is aballoon-on-a-wire device comprising two balloons located near the distalend of the device in spaced apart relation. The balloon-on-a-wire device510 comprises wire catheter 511 having at least one cut in its outersurface and a polymer film covering (as discussed above). The wirecatheter 511 also includes at least one generally centrally locatedlumen 511 that extends from a port at the proximal end (or near theproximal end) of the wire catheter 511 to the interior space of firstballoon 513, and, optionally, the interior space of second balloon 514.Finally, the device includes atraumatic tip 515. The device can includeat least a second lumen that can extend from a port at the proximal end(or near the proximal end) of the wire catheter 511 to the interiorspace of the second balloon. Although the first and second balloons maybe either dilatation balloons or occlusion balloons, in an aspect of theinvention the balloons are occlusion balloons. Such a device may beparticularly suitable for thrombus removal from a patient's cerebralvasculature.

For example, the device can be sized to be capable of being advanceddeep into a patient's cerebral vasculature, with or without the use of amicrocatheter or guide sheath to aid the device in being advanced. Themost distal balloon can be advanced just distal to the thrombus and theproximal balloon located proximal to the thrombus. The balloons can beinflated (one at a time, or simultaneously) and the thrombus removed byretracting the balloon-on-a-wire device.

Turning now to FIGS. 26 and 27 there is shown a combination of awire-based device and a microcatheter. The microcatheter 520 is a rapidexchange type microcatheter construction and comprises a shaft having alength, an outer surface, a proximal end 521, a distal end 522, and afirst longitudinally extending catheter lumen 523 and a secondlongitudinally extending lumen 524. The first longitudinally extendingcatheter lumen 523 extends from the proximal end 521 to the distal end522. The second longitudinally extending catheter lumen 524 extends froma first port 525 at the distal end to a second port 526 located proximalto the distal end and distal to the proximal end. A wire-based device527 according to the invention is slidably locatable within the secondlongitudinally extending catheter lumen 524, as shown in FIG. 27. Thewire-based device 527 comprises a length, an outer surface having atleast one cut therein, and polymer film 528 covering at least a portionof the outer surface of the wire shaft. The device further comprises adistal end 529 and a proximal end 530, an inner surface defining alongitudinally extending wire lumen (not shown) extending from theproximal end 530 to a point distal thereto, and an expandable balloon531 with an interior space located near the wire distal end 529. Furthershown is atraumatic tip 532 which can be attached to the wire distal end529.

In an aspect of the invention, the microcatheter has a length of fromabout 75 cm to about 150 cm. Moreover, the microcatheter preferably hasa crossing profile of from about 3 french to about 6 french. Thewire-based device is preferably sized to be capable of being advancedinto a patient's cerebral vasculature. For example, a wire-based deviceof this embodiment can have a length of from about 90 cm to about 180cm. Moreover, the wire-based device can have a crossing profile equal tostandard guidewire devices. The device will be capable of being moved toand fro within the second longitudinally extending lumen 524 of themicrocatheter 520. In an aspect of the invention the second port 526 canbe located relatively closer to the distal end of the microcatheter andrelatively further from the proximal end of the microcatheter. In afurther aspect of the invention the second port 526 can be located fromabout 5 cm to about 30 cm from the distal end 522 of the microcatheter.In a further aspect of the invention the longitudinally extending wirelumen extends from the wire proximal end to a point near the distal endand is in fluid communication with the interior space of the expandableballoon 531.

A still further embodiment of the wire-based device is shown in FIG. 28.As shown, the device is a balloon-on-a-wire device 540 comprising anelongated wire 541 having a length, an inner surface defining alongitudinally extending lumen (not shown), an outer surface having atleast one cut therein, polymer film 542 covering at least a portion ofthe outer surface, a proximal end 543, a distal end 544, a proximalsection 555 having a first outer diameter, and a distal section 556having a second outer diameter that is less than the first outerdiameter. The device further comprises expandable balloon 557 having aninterior, a compressed state, an expanded state, a proximal end 558, anda distal end 559, the distal end 559 of the balloon 557 being sealed tothe wire device distal section 556. The expandable balloon interior isin fluid communication with the longitudinally extending lumen. In anaspect of the invention the device further comprises atraumatic tip 560attached to the wire distal end 544. In a further aspect of theinvention the balloon proximal end 558 can be sealed to the wireproximal section 555. In a still further aspect of the invention theballoon proximal end 558 can be sealed to the wire distal section 556.

In an aspect of the invention the expandable balloon 557 in itscompressed state has an outer diameter substantially equal to or lessthan the first outer diameter of the wire.

In an aspect of the invention, the device can have a length of fromabout 75 cm to about 150 cm. Advantages offered by the device include,but are not limited to, crossing profile is substantially the same overthe length of the device and can be the same as that of a standardguidewire. Moreover, the device can serve as a guide wire, allowing fora second device to be advanced over it to treat a target region. Forexample, the device could be advanced to a first target region, thetarget, such as a stenosis, can be treated (e.g., dilated with adilatation balloon on the balloon-on-a-wire device), then a catheter canbe advanced over the device to treat a region distal to the first targetregion. Since the crossing profile of the balloon-on-a-wire device issubstantially the same over the length of the device, the catheter canbe easily passed over the balloon of the balloon-on-a-wire device.

A still further embodiment of the wire-based device is shown in FIG. 29.As shown, the device is a catheter 600 comprising an elongated catheterbody 610 having a length, a proximal end 611, and a distal end 612. Thedevice further comprises at least a first lumen 615 and a second lumen616 which extends distally from the proximal end 611 of the elongatedcatheter body 610. The second lumen 616 terminates at a port 618 locatedproximal of expandable balloon 620. The expandable balloon 620 has aninterior space and is located near the distal end 612 of the catheterbody 610. The interior space of the expandable balloon is in fluidcommunication with the first lumen 615. Preferably the balloon is adilatation balloon. In some embodiments, a stent 621 is loaded onto theballoon. The first lumen 615 and/or second lumen 616 can be providedwith a first component having a change in stiffness from a first pointto a second point. In the first lumen 615 the first component can extendto a point distal to the port 618 of the second lumen 616. In the secondlumen 616 the second component can extend essentially from the proximalend to the port 618. This first component may be a hollow tube, a wire,or braiding. Preferably the first component is a hollow tube comprisinga metal. In a preferred embodiment, the first component comprises ahypotube.

As further shown in FIG. 29, this embodiment may further comprise aballoon on a wire device 625 slidably located within the second lumen616 of the catheter body 610. In a preferred embodiment, either thecatheter, the balloon on a wire device, or both the catheter and theballoon on wire device further comprise at least one radiopaquematerial.

The catheter may further comprise a third lumen 617 extending proximallyfrom a port 619 at the distal end 612. In one embodiment, the thirdlumen 617 extends from the distal port 619 to a port (not shown) at theproximal end. Alternatively, the third lumen 617 may extend from thedistal port 619 to a port (not shown) located proximal to the expandableballoon and distal to the proximal end 611 of the catheter.

A further aspect of the invention comprises a method for advancingcatheters and/or balloon-on-a-wire devices distally into tortuousarteries. The method includes the use of a balloon-on-a-wire deviceaccording to the invention. The balloon-on-a-wire device is used intandem with a catheter having an expandable balloon on the distal endthereof and a guide-wire receiving lumen extending from the proximal end(or near the proximal end) to a point distal to the expandable balloon,and preferably to the distal end of the catheter.

The method allows for the relatively easy advancement of theballoon-on-a-wire device and a balloon catheter into tortuousvasculature by alternating using each device as an anchor whileadvancing the other device distally into the vasculature.

The method includes the steps of providing a balloon catheter devicehaving a length, a proximal end, a distal end, an outer surface, a firstlongitudinally extending catheter lumen extending from the proximal endto near the distal end, and a second longitudinally extending catheterlumen, the second longitudinally extending catheter lumen extendingproximally from a distal port at the distal end of the balloon catheterdevice; and a first expandable balloon having an interior space at thecatheter distal end, the balloon interior space being in fluidcommunication with the first longitudinally extending catheter lumen;providing a balloon-on-a-wire device comprising an elongated wire havinga length, a proximal end, a distal end, an outer surface, having atleast one cut therein, polymer film covering at least a portion of theouter surface, and an inner surface, the inner surface defining alongitudinally extending wire lumen; and a second expandable balloonhaving an interior space at the wire distal end, the balloon interiorspace being in fluid communication with the longitudinally extendingwire lumen wherein at least a portion of the balloon-on-a-wire device isslidably located within the second longitudinally extending catheterlumen; advancing the balloon catheter device and the balloon-on-a-wiredevice into a patient's vasculature, toward a treatment site; andadvancing the second expandable balloon to a point distal to thecatheter distal port and expanding the second expandable balloon; andwhile the second expandable balloon is expanded, distally advancing theballoon catheter device. Thereafter, the first expandable balloon can beexpanded and the second expandable balloon contracted, and, while thefirst expandable balloon is expanded, distally advance theballoon-on-a-wire device.

In an aspect of the invention the second longitudinally extendingcatheter lumen extends proximally from the distal port to a proximalport located proximal to the first expandable balloon. In a furtheraspect of the invention the proximal port can be located at the ballooncatheter proximal end. Moreover, the proximal port can be located distalto the balloon catheter proximal end. In a still further aspect of theinvention the proximal port can be located relatively close to thedistal port and relatively further from the balloon catheter proximalend.

In a still further aspect of the invention a balloon on a wire devicecomprises:

-   -   a proximal elongated wire having a length, an inner surface        defining a longitudinally extending lumen, an outer surface        having at least one cut therein, polymer film covering at least        a portion of the outer surface, a proximal end, a distal end,        and an outer diameter;    -   an intermediate elongated wire having a length, an inner surface        defining a longitudinally extending lumen, an outer surface, a        proximal end attached to the distal end of the proximal        elongated wire, a distal end, and an outer diameter that is less        than the proximal wire outer diameter;    -   a distal elongated wire having a length, an inner surface        defining a longitudinally extending lumen, an outer surface, a        proximal end attached to the distal end of the intermediate        wire, a distal end, and an outer diameter that is greater than        the intermediate wire outer diameter;    -   an expandable balloon located over the intermediate elongated        wire and sealed to the device, the expandable balloon having an        interior, an outer surface, a compressed state, an expanded        state, a proximal end, and a distal end; and    -   the expandable balloon interior being in fluid communication        with at least one of the proximal wire lumen, the intermediate        wire lumen, and the distal wire lumen through a port provided in        at least one of the proximal, intermediate, and distal wires.

Either or both of the intermediate elongated wire and the distalelongated wire can further comprise at least one cut in the outersurface, the at least one cut can extend through to an inner surface ofeither or both of the intermediate and distal elongated wires. The atleast one cut in the proximal, intermediate, and/or distal elongatedwire can be spirally extending for any desired length of each wire andpreferably extends through to the inner surface thereof.

Moreover, either or both of the intermediate elongated wire and thedistal elongated wire can further comprise polymer film covering atleast a portion of the outer surface thereof.

This aspect of the invention may be better understood with reference toFIG. 30 wherein a non-limiting example is shown.

Shown in longitudinal cross section is balloon on a wire device 700. Thedevice 700 has a proximal end 701 and a distal end 702 and furtherincludes proximal elongated wire 703, having a length, an inner surfacedefining a longitudinally extending lumen 704, an outer surface 705having at least one cut 706 therein, polymer film 707 covering at leasta portion of the outer surface 705 of the wire, a proximal end 708, adistal end 709, and having an outer diameter. The device furtherincludes intermediate elongated wire 710 having a length, an innersurface defining a longitudinally extending lumen 711, an outer surface712, a proximal end 713 attached to the distal end of the proximalelongated wire, a distal end 714, and an outer diameter that is lessthan the proximal wire outer diameter. The device still further includesdistal elongated wire 720 having a length, an inner surface defining alongitudinally extending lumen 721, an outer surface 722, a proximal end723 attached to the distal end of the intermediate elongated wire, adistal end 724, and an outer diameter that is greater than theintermediate wire outer diameter. The device also includes expandableballoon 730 having a proximal end 731 sealed to the distal end of theproximal elongated wire and a distal end 732 sealed to the proximal endof the distal elongated wire. The balloon interior is in fluidcommunication with the lumen 711 of the intermediate wire 710 throughport 733. The device can further include atraumatic tip 740 (such as acoil) attached to the distal end 724 of the distal elongated wire 720.Also shown is optional stent 750 loaded over balloon 730. The stent 750has a length, an inner diameter, an outer diameter, a compressed stateand an expanded state. In an aspect of the invention the diameter of thestent in its compressed state is equal to or less than the diameters ofthe proximal and distal ends of the balloon in its compressed state.Although the balloon 730 is shown with the distal end sealed to theproximal end of the distal elongated wire and the proximal end sealed tothe distal end of the proximal elongated wire, the balloon ends can besealed to any of the proximal elongated wire, the intermediate elongatedwire and the distal elongated wire. In an aspect of the invention, theballoon distal end is sealed to the distal end of the intermediateelongated wire and the balloon proximal end is sealed to the proximalend of the intermediate elongated wire.

1. Catheter comprising: a first longitudinally extending hollow polymertube having a proximal end, a distal end, a wall having an inner surfaceand an outer surface, and a centrally located lumen extending from theproximal end to the distal end; a channel located in the wall forming anopening in the outer surface of the wall and extending from the proximalend to the distal end; polymer film helically wrapped about the outersurface, covering the channel from the proximal end to the distal end,thus covering the opening in the outer surface and forming a first wallinflation lumen extending from the proximal end to the distal end; andan inflatable member located on the distal end the catheter, theinflatable member selected from the group consisting of an occlusionballoon and a dilation balloon and being in fluid communication with theinflation lumen.
 2. The catheter of claim 1 further comprising a secondlongitudinally extending hollow tube having a proximal end and a distalend, a wall having an inner surface and an outer surface, and acentrally located lumen extending from the proximal end to the distalend, wherein the second longitudinally extending hollow tube is locatedinside the first longitudinally extending hollow tube with the innersurface of the first tube being in contact with the outer surface of thesecond tube.
 3. The catheter of claim 2, wherein the first polymer tubeencapsulates a metal braid material.
 4. The catheter of claim 3, whereinthe first polymer tube comprises polyamide.
 5. The catheter of claim 2,wherein the second tube comprises polytetrafluoroethylene.
 6. Thecatheter of claim 5, wherein the polytetrafluoroethylene is extrudedpolytetrafluoroethylene.
 7. The catheter of claim 2, wherein thecatheter is sized to be capable of being advanced into a patient'scerebral vasculature.
 8. The catheter of claim 1, wherein the polymerfilm comprises a material selected from the group consisting ofultra-high molecular weight polyethylene, polypropylene, polyamide,polyethylene terephthalate, fluorinated ethylene propylene, perfluoroalkoxy resin, polyurethane, polyester, and polyimide.
 9. The catheter ofclaim 1, wherein the polymer film comprises polytetrafluoroethylene. 10.The catheter of claim 9, wherein the polymer film comprises expandedpolytetrafluoroethylene.
 11. The catheter of claim 10, wherein theexpanded polytetrafluoroethylene is provided with a thermoplasticcoating.
 12. The catheter of claim 11, wherein the thermoplastic coatingis a non-porous coating.
 13. The catheter of claim 12, wherein thethermoplastic coating comprises fluorinated ethylene propylene.
 14. Thecatheter of claim 10, wherein the expanded polytetrafluoroethylene isimbibed with at least one filler material.
 15. The catheter of claim 14,wherein the at least one filler material comprises a radiopaquematerial.
 16. The catheter of claim 1, wherein the channel is formed bya laser.
 17. The catheter of claim 1, wherein the polymer film ishelically wrapper about the outer surface of the first longitudinallyextending hollow tube.
 18. The catheter of claim 1, wherein the channelis a longitudinally extending channel.
 19. The catheter of claim 1,wherein a guidewire is in sliding relationship with the centrallylocated lumen of the first longitudinally extending hollow tube.
 20. Thecatheter of claim 1, wherein the catheter is sized to be capable ofbeing advanced into a patient's cerebral vasculature.
 21. The catheterof claim 1, wherein the inflatable member is an occlusion balloon. 22.The catheter of claim 1, wherein the inflatabled member is a dilatationballoon.
 23. The catheter of claim 1, wherein a stent is mounted on thedilatation balloon.
 24. The catheter of claim 1, further comprising atleast a second channel located in the wall forming at least a secondopening in the outer surface of the wall.
 25. The catheter of claim 24,wherein the second channel extends from the proximal end to the distalend of the catheter.
 26. The catheter of claim 24, wherein the polymerfilm covers the at least second opening in the outer surface of thewall, forming at least a second wall lumen.
 27. The catheter of claim26, wherein the second wall lumen extends from the proximal end to thedistal end of the catheter.
 28. The catheter of claim 24, wherein the atleast second channel is a longitudinally extending channel.
 29. Thecatheter of claim 1, wherein the polymer film is provided with anadhesive material to at least a portion of at least one side of thepolymer film.
 30. The catheter of claim 29, wherein the adhesivecomprises a UV-curable adhesive.
 31. Catheter comprising: a firstlongitudinally extending hollow polymer tube having a proximal end, adistal end, a wall having an inner surface and an outer surface, and acentrally located lumen extending from the proximal end to the distalend; a channel located in the wall forming an opening in the outersurface of the wall and extending from the proximal end to near thedistal end; polymer film helically wrapped about the outer surface,covering the channel from the proximal end to near the distal end, thuscovering the opening in the outer surface and forming a first wallinflation lumen extending from the proximal end to near the distal end;and an inflatable member located on the distal end of the catheter, theinflatable member selected from the group consisting of an occlusionballoon and a dilation balloon and being in fluid communication with theinflation lumen.
 32. The catheter of claim 31, further comprising asecond longitudinally extending hollow tube having a proximal end and adistal end, a wall having an inner surface and an outer surface, and acentrally located lumen extending from the proximal end to the distalend, wherein the second longitudinally extending hollow tube is locatedinside the first longitudinally extending hollow tube with the innersurface of the first tube being in contact with the outer surface of thesecond tube.
 33. The catheter of claim 32, wherein the first polymertube encapsulates a metal braid material.
 34. The catheter of claim 33,wherein the first polymer tube comprises polyamide.
 35. The catheter ofclaim 32, wherein the second tube comprises polytetrafluoroethylene. 36.The catheter of claim 35, wherein the polytetrafluoroethylene isextruded polytetrafluoroethylene.
 37. The catheter of claim 32, whereinthe catheter is sized to be capable of being advanced into a patientscerebral vasculature.
 38. The catheter of claim 31, wherein the polymerfilm comprises a material selected from the group consisting ofultra-high molecular weight polyethylene, polypropylene, polyamide,polyethylene terephthalate, fluorinated ethylene propylene, perfluoroalkoxy resin, polyurethane, polyester, and polyimide.
 39. The catheterof claim 31, wherein the polymer film comprises polytetrafluoroethylene.40. The catheter of claim 39, wherein the polymer film comprisesexpanded polytetrafluoroethylene.
 41. The catheter of claim 40, whereinthe expanded polytetrafluoroethylene is provided with a thermoplasticcoating.
 42. The catheter of claim 41, wherein the thermoplastic coatingis a non-porous coating.
 43. The catheter of claim 42, wherein thethermoplastic coating comprises fluorinated ethylene propylene.
 44. Thecatheter of claim 40, wherein the expanded polytetrafluoroethylene isimbibed with at least one filler material.
 45. The catheter of claim 44,wherein the at least one filler material comprises a radiopaquematerial.
 46. The catheter of claim 31, wherein the channel is a formedby a laser.
 47. The catheter of claim 31, wherein the polymer film ishelically wrapped about the outer surface of the first longitudinallyextending hollow tube.
 48. The catheter of claim 31, wherein the channelis a longitudinally extending channel.
 49. The catheter of claim 31,wherein a guidewire is in sliding relationship with the centrallylocated lumen of the first longitudinally extending hollow tube.
 50. Thecatheter of claim 31, wherein the catheter is sized to be capable ofbeing advanced into a patient's cerebral vasculature.
 51. The catheterof claim 31, wherein the inflatable member is an occlusion balloon. 52.The catheter of claim 31, wherein the inflatable member is a dilatationballoon.
 53. The catheter of claim 31, wherein a stent is mounted on thedilatation balloon.
 54. The catheter of claim 31, further comprising atleast a second channel located in the wall forming at least a secondopening in the outer surface of the wall.
 55. The catheter of claim 54,wherein the second channel extends from the proximal end to the distalend of the catheter.
 56. The catheter of claim 54, wherein the polymerfilm covers the at least second opening in the outer surface of thewall, forming at least a second wall lumen.
 57. The catheter of claim56, wherein the second wall lumen extends from the proximal end to thedistal end of the catheter.
 58. The catheter of claim 54, wherein the atleast second channel is a longitudinally extending channel.
 59. Thecatheter of claim 31, wherein the polymer film is provided with anadhesive material to at least a portion of at least one side of thepolymer film.
 60. The catheter of claim 59, wherein the adhesivecomprises a UV-curable adhesive.